Director, Early Phase Biostatistics Daiichi Sankyo, Inc.Director, Early Phase BiostatisticsBasking Ridge, NJ$201,840–$302,760 / yearFull timeMentoring and Coaching Junior Statisticians: Mentoring the study level statisticians for the assigned projects to ensure optimal statistical handling and quality deliverables including Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR). Drug Development Strategy: Provides input to the clinical development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies’ requirements for countries and regions the drug is to be submitted.
Associate Director, Biostatistics (Late Stage) Daiichi Sankyo, Inc.Associate Director, Biostatistics (Late Stage)Basking Ridge, NJ$175,440–$263,160 / yearFull timeProtocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. May participate in meeting or teleconferences with Health Authorities Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
Director, Biostatistics - Remote Agios PharmaceuticalsDirector, Biostatistics - RemoteNew York, NYRemote$183,000–$275,000 / yearThe current base salary range for this position is expected to be between $183,000 and $275,000 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Director will serve as the lead statistician for assigned clinical development programs, leading the development and implementation of statistical solutions to support all phases of clinical trials, regulatory filing and facilitating decision-making.
Head of Global Biostatistics Daiichi Sankyo, Inc.Head of Global BiostatisticsBasking Ridge, NJ$271,500–$452,500 / yearFull timeProvides regular status updates on projects, metrics and KPIs to Head of BDM and BDM LT External Vendor Oversight: Provides oversight of and is accountable for the quality/performance and budget, resources and timelines across the department and ensures timely delivery of high-quality deliverables at reasonable cost. This role also serves as a key member of the BDM leadership team, contributing to BDM broader organizational strategy, cross-functional decision-making, and the advancement of BDM objectives beyond the Biostatistics function.
Principal Statistical Programmer, Biometrics - Remote Agios PharmaceuticalsPrincipal Statistical Programmer, Biometrics - RemoteNew York, NYRemote$131,035–$196,553 / yearThe current base salary range for this Senior Manager position is expected to be between $131,035 and $196,553 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
Associate Director, Biostatistics Everest Clinical ResearchAssociate Director, BiostatisticsBridgewater, New JerseyRemoteTo drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as Associate Director, Biostatistics (Statistical Operations) for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. Review and provide input to clinical data management deliverables, including but not limited to the following: electronic Case Report Forms (eCRFs), eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan (DMP).
Senior Director, Biostatistics Spyre Therapeutics IncSenior Director, BiostatisticsNY$275,000–$290,000 / yearThis is a hands-on role where you will interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, conduct ad-hoc analyses, and manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files. Participate in cross-functional study-related activities; Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines.
Director, Biostatistics Tempus AI IncDirector, BiostatisticsNY$180,000–$240,000 / yearSalary Range: CHI: $180,000-$240,000 USD NYC/SF: $190,000-$260,000 The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). We are seeking a highly motivated and capable Director of Biostatistics to lead a team of biostatisticians involved in multiple aspects of clinical research at Tempus.
Associate Director, Biostatistics in Princeton, New Jersey, United States of America | Research & Discovery at Genmab Government of DenmarkAssociate Director, Biostatistics in Princeton, New Jersey, United States of America | Research & Discovery at GenmabPrinceton, NJAssociate Director, Biostatistics in Princeton, New Jersey, United States of America | Research & Discovery at Genmab Skip to main content Skip to main content Healthcare Professionals Patients & Care Partners Partnerships Contact Working at Genmab Career Areas Application Process Locations Talent Community Job Search Corporate Sign in Close the popup Sign in to Phenom Careers Enjoy a personalized jobs search Sign in with Google Employee Login Sign in with Google Sign up Saved jobs (0) Healthcare Professionals Patients & Care Partners Partnerships Contact Saved jobs (0) Toggle navigation - - Recruitment Fraud Warning: Please note that Genmab never requests payment, banking details, or Social Security numbers during the recruitment process. Close Covid-19 banner Associate Director, Biostatistics Category Research & Discovery Job Id R15202 Remote This job available in 3 locations Princeton, New Jersey, United States of America Copenhagen, Capital, Denmark Utrecht, Netherlands Save Apply Now We are extra[not]ordinary*(ex· tra· not· or· di· nary |\ ik- str-not- r-d - ner- ) Adjective: A unique word for Genmab meaning to go way beyond what is usual; to be remarkable; proudly unique and authentic Back to search results Previous job Next job JOB DESCRIPTION At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases.
Associate Director Biostatistics Penfield Search PartnersAssociate Director BiostatisticsPrinceton, NJContribute to the development and implementation of innovation in statistical methodology and trial design; perform simulations to assess various study design options and analysis approaches. Currently they are seeking an Associate Director of Biostatistics to support registration-directed clinical development programs and global regulatory submissions.
Senior Scientist, Biostatistics - Oncology Johnson and JohnsonSenior Scientist, Biostatistics - OncologyRaritan, NJRemoteFull timeThe Senior Scientist, Biostatistics will support the Oncology Therapeutic Area with a focus on: solid tumors or hematologic malignancies; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualized use of our therapies; as well as safe and effective identification and treatment of early changes in the tumor microenvironment. Raritan, New Jersey, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America.
Associate Director, Biostatistics & AI BridgeBio Pharma IncAssociate Director, Biostatistics & AINY$173,800–$217,000 / yearThe Associate Director, Biostatistics & AI is a senior individual contributor and emerging people leader responsible for the delivery of high-quality statistical analyses and for designing, building, and embedding AI/ML interfaces into the day-to-day workflows of the biometrics function. They will work across cross-functional teams including Clinical Development, Regulatory Affairs, Medical Affairs, and Pharmacovigilance, and will manage CRO statisticians and programmers on assigned programs.
Deputy Director - Senior Project Biostatistics Lead- Vaccines SanofiDeputy Director - Senior Project Biostatistics Lead- VaccinesMorristown, NJ$148.50–$214.50 / hourAs Deputy Director - Senior Project Biostatistics Lead - Vaccines within our R&D team, you will serve as a Senior Biostatistics Expert at the vaccine project level, playing a critical role in developing end-to-end clinical development plans and contributing to the advancement of life-saving vaccines. Additionally, you will communicate trial results internally, work cross-functionally on scientific interpretation and strategic impact evaluation, contribute to external communication of study results to Health Authorities, and be accountable for the statistical aspects of submissions for marketing authorization or label improvement.
Associate Director, Biostatistics Sun Pharmaceutical Industries LtdAssociate Director, BiostatisticsPrinceton, NJ$186,500–$207,000 / yearUse teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required. Reporting to a Director, Biostatistics Lead, this position will be responsible for supporting the design, execution, analysis and interpretation of registration-directed clinical trials and global regulatory submissions.
Senior Manager, Biostatistics Axsome Therapeutics IncSenior Manager, BiostatisticsNYRemote$140,000–$170,000 / yearOur industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer's disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Reporting to the Senior Director, Biostatistics, the Senior Manager, Biostatistics will serve as lead statistician on assigned clinical trials, and in collaboration with project team members provide statistical input on trial design, protocol development, and manage creation of Statistical Analysis Plans (SAPs).
Manager, Biostatistics - Medical Affairs Regeneron Pharmaceuticals IncManager, Biostatistics - Medical AffairsNY$128,600–$210,000 / yearTogether with medical directors, HEOR, medical writing, market access, and other colleagues within medical affairs, you will plan and execute evidence generation efforts, such as post-hoc analysis with innovative analytical approaches, respond to payer and reimbursement needs, review investigator initiated studies, and design and execute Phase IV studies as the study biostatistician, and ensure statistical rigor in all these duties. Working in a dynamic team with a wide range of interfaces, the role requires both strategic and operational skills combining innovative statistical thinking with a strong sense of business acumen, and excellent communication and interpersonal skills.
Associate Director, Biostatistics Genmab ASAssociate Director, BiostatisticsPrinceton, NJFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Associate Director, Biostatistics - Genetic Medicine Regeneron Pharmaceuticals IncAssociate Director, Biostatistics - Genetic MedicineNY$176,100–$287,300 / yearIn this role, a typical day might include: The incumbent will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. Lead contributions to the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc.
NewAssociate Director, Biostatistics Merck & Co IncAssociate Director, BiostatisticsRahway, NJ$142,400–$224,100 / yearRequired Skills: Assay, Assay Development, Clinical Research, Clinical Trials, Cross-Functional Collaboration, Cross-Team Collaboration, Data Management, Data Science, Early Clinical Development, Numerical Analysis, Scientific Modeling, Statistical Programming, Teamwork, Waterfall Model. Acting as a statistical expert in regulatory submissions and compliance - responsible for supporting the submission of study results to regulatory agencies such as the FDA, EMA, USDA, and EPA; interacting with regulatory authorities on statistical issues related to product development, registration, investigations.
NewPrincipal Scientist, Biostatistics, Clinical Safety Statistics Merck & Co IncPrincipal Scientist, Biostatistics, Clinical Safety StatisticsRahway, NJ$190,800–$300,300 / yearIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Required Skills: Biostatistics, Clinical Risk Management, Clinical Study Design, Clinical Trials, Clinical Trials Analysis, Data Management, Data Science, Numerical Analysis, Safety Management, Statistical Analysis, Statistical Software, Strategic Management, Strategic Planning.
NewPrincipal Scientist, Biostatistics Merck & Co IncPrincipal Scientist, BiostatisticsRahway, NJ$190,800–$300,300 / yearIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position involves interaction with Medical, Data Coordination, Statistical Programming, our Research & Development Division scientists and Regulatory staffs in designing and analyzing clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or programming staff assigned to a development project as needed.
Senior Manager, Biostatistics (RWD/RWE) BeOne Medicines AGSenior Manager, Biostatistics (RWD/RWE)NY$155,000–$200,000 / yearEducation Required: Senior Manager, Biostatistics: PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 2 years relevant work experience, or a Master's degree with a minimum of 4 years relevant work experience. Other Qualifications: Senior Manager, Biostatistics: PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 2 years relevant work experience, or a Master's degree with a minimum of 4 years relevant work experience.
Director, Data Management & Biostatistics Amneal Pharmaceuticals IncDirector, Data Management & BiostatisticsBridgewater, NJ$250,000–$280,000 / yearThe Director partners closely with Clinical Development, Medical Affairs, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Quality, and external partners to deliver high-quality, inspection-ready data and analyses in accordance with FDA, EMA, ICH, and GxP requirements. Description: The Director, Data Management & Biostatistics provides strategic and operational leadership for all data management, biostatistics, and statistical programming activities supporting the company''s pharmaceutical development portfolio.
Biostatistics Director, Medical Affairs BridgeBio Pharma IncBiostatistics Director, Medical AffairsNY$222,300–$255,000 / yearThis includes, but is not limited to, providing scientific and methodological expertise to support medical strategy, publications, and external engagements; serving as the primary point of contact between biostatistics and the Medical Affairs team; collaborating with the team in development of publication strategy plans; maintaining and executing Supplemental Statistical Analysis Plans (SAPs); and assisting as needed with real-world evidence-generating requests. They interact with both internal and external cross-functional study teams to support the scientific communication effort, and partner with unblinded biometrics study team members to deliver needed statistical output in a timely fashion.
Associate/Full Professor, Biostatistics-Tenure Track Albert Einstein College of MedicineAssociate/Full Professor, Biostatistics-Tenure TrackBronx, New YorkBiostatistics faculty collaborate widely across the institution; teach in the medical and graduate educational programs; and lead and participate in biostatistics resources in the ICTR, Montefiore Einstein Comprehensive Cancer Center, Center for AIDS Research, Einstein Aging Study, and other research programs. The Division of Biostatistics in the Department of Epidemiology and Population Health includes more than 20 faculty members with active research programs in clinical trials methodology, statistical genetics and genomics, epidemiologic methods, machine learning, and analysis of real-world data.
Senior Director Oncology Biostatistics Bristol-Myers Squibb CoSenior Director Oncology BiostatisticsNJ$279,410–$338,582 / yearThe Senior Director provides expertise and guidance in collaboration with cross-functional groups broadly across the organization in establishing study design and analyses and strategy, and institutes best practices with regards to planning, execution, interpretation and regulatory submission of clinical projects and studies. Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Director, Biostatistics Hematology Bristol-Myers Squibb CoDirector, Biostatistics HematologyNJ$216,570–$262,434 / yearPhD (9+ years experience) or MS (11+ years experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience, Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation. Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Senior Director, Biostatistics Immunovant IncSenior Director, BiostatisticsNY$270,000–$310,000 / yearProvide scientifically rigorous statistical input into clinical development plans, protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
Senior Manager, Biostatistics Axsome TherapeuticsSenior Manager, BiostatisticsNew York, NYRemote$140,000–$170,000 / yearOur industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer's disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Reporting to the Senior Director, Biostatistics, the Senior Manager, Biostatistics will serve as lead statistician on assigned clinical trials, and in collaboration with project team members provide statistical input on trial design, protocol development, and manage creation of Statistical Analysis Plans (SAPs).
NewManager, Biostatistics Regeneron Pharmaceuticals IncManager, BiostatisticsNY$128,600–$210,000 / yearThe incumbent will work with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. Is involved in research activities for innovative statistical methods and applications in clinical trial development (e.g., external control arms, hybrid designs, master protocols), with expectation of publications and methodological contributions, as well as providing training to non-statisticians.
Senior Director, Biostatistics - Immunology & Inflammation Regeneron Pharmaceuticals IncSenior Director, Biostatistics - Immunology & InflammationNJD. in statistics or related discipline with 10+ years of experience (or MS in statistics or related discipline with 15+ years) in the biotechnology, pharmaceutical or health related industry, including significant interaction with both FDA and EMEA, history of successful project and people management (6+ years), and expertise in multiple therapeutic areas. They must also possess excellent communication skills to interface with senior leadership on behalf of the department and work closely with medical study directors to provide and receive direction on clinical programs and have the ability to influence the medical and clinical teams.
Adjunct Instructor (Per Diem) Biostatistics Rutgers The State University of New JerseyAdjunct Instructor (Per Diem) BiostatisticsPiscataway, NJ$60–$80 / hourImmunization Requirements Under Policy 100.3.1 Immunization Policy for Covered Individuals if employment will commence during Flu Season Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season unless the University has granted the individual a medical or religious exemption. The specific benefits vary based on the position and may include: • Medical • Prescription drug • Dental coverage • Paid vacation • Holidays • Various leave programs • Competitive retirement benefits including defined contribution plans and voluntary tax-deferred savings options • Employee and dependent educational benefits when applicable • Life insurance coverage • Employee discount programs.
Director of Biostatistics Oruka Therapeutics IncDirector of BiostatisticsNYRemote$213,000–$240,000 / yearOruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Capability to provide statistical leadership to cross-functional teams at the study and project level, exercise independent judgement and provide oversight to junior statisticians.
Director, Biostatistics Agios Pharmaceuticals IncDirector, BiostatisticsNY$183,000–$275,000 / yearThe current base salary range for this position is expected to be between $183,000 and $275,000 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Director will serve as the lead statistician for assigned clinical development programs, leading the development and implementation of statistical solutions to support all phases of clinical trials, regulatory filing and facilitating decision-making.
NewSenior Manager, Biostatistics Insmed IncSenior Manager, BiostatisticsNJRemote$133,000–$173,000 / yearFor New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress.
Associate Director, Biostatistics BeOne Medicines AGAssociate Director, BiostatisticsNY$162,600–$212,600 / yearGeneral Description: Work with cross-functional study/project teams supporting hematology studies and interact with Clinical, Regulatory, Statistical Programming, Data Management and other Research Scientists in reviewing the data, developing and implementing the statistical analysis plan (SAP) for the clinical study report (CSR) and other. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.
Director, Biostatistics Bristol-Myers Squibb CoDirector, BiostatisticsMadison, NJ$218,740–$265,060 / yearPhD (9+ years experience) or MS (11+ years experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience, Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation. Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Senior Principal Statistical Programmer Katalyst Healthcares & Life SciencesSenior Principal Statistical ProgrammerParamus, NJThe Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing. Duties and Responsibilities: Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.
Senior Principal Statistical Programmer Karwell TechnologiesSenior Principal Statistical ProgrammerParamus, NJThe Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing. Responsibilities: Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.
FSP Principal Statistical Programmer (Remote) Everest Clinical ResearchFSP Principal Statistical Programmer (Remote)Bridgewater, New JerseyRemoteTo drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as FSP Principal Statistical Programmer for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I – IV clinical trials, integrated clinical summaries, responses to requests from regulatory agencies, publication support, data explorations, data monitoring committee meetings, etc.
Associate Director, Statistical Programming Everest Clinical ResearchAssociate Director, Statistical ProgrammingBridgewater, New JerseyRemoteTo drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Associate Director, Statistical Programming for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. When required, review and provide input to clinical data management deliverables including, but not limited to, the following: electronic Case Report Forms (eCRFs), eCRF Completion Instructions, data validation specifications, Data Review Plan (Plan; and the ongoing data review TLFs in accordance with the Plan), and Data Management Plan (DMP).
Lead Statistical Programmer Katalyst Healthcares & Life SciencesLead Statistical ProgrammerTarrytown, NYProvide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities. Create statistical analysis outputs to be used in support of final reports, abstracts, posters, Manu scripts, and other clinical publications; support systems to produce electronic regulatory submissions.
Lead Statistical Programmer Karwell TechnologiesLead Statistical ProgrammerNewark, NJProvide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities. Create statistical analysis outputs to be used in support of final reports, abstracts, posters, Manu scripts, and other clinical publications; support systems to produce electronic regulatory submissions.
Principal Statistical Programmer (Remote) Everest Clinical ResearchPrincipal Statistical Programmer (Remote)Bridgewater, New JerseyRemoteTo drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Principal Statistical Programmer for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I – IV clinical trials, integrated clinical summaries, responses to requests from regulatory agencies, publication support, data explorations, data monitoring committee meetings, etc.
Senior Statistical Programmer (Remote) Everest Clinical ResearchSenior Statistical Programmer (Remote)New JerseyRemoteTo drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Statistical Programmer for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.
Senior Statistician Katalyst Healthcares & Life SciencesSenior StatisticianEdison, NJThe Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing. Responsibilities: Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.
Senior Biostatistician Rutgers The State University of New JerseySenior BiostatisticianNew Brunswick, NJAligned with Rutgers University-New Brunswick and collaborating university wide, RBHS includes eight schools, a behavioral health network, and five centers and institutes that focus on cancer treatment and research, neuroscience, advanced biotechnology and medicine, environmental and occupational health, and health care policy and aging research. Under Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption.
Senior Statistician Karwell TechnologiesSenior StatisticianEdison, NJThe Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing. Responsibilities: Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.
NewSenior Scientist, Statistical Programming, SDTM (Hybrid) Merck & Co IncSenior Scientist, Statistical Programming, SDTM (Hybrid)Rahway, NJ$117,000–$184,200 / yearIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Required Skills: Clinical Trials, Data Management, Data Modeling, Electronic Submissions, Project Management, Stakeholder Relationship Management, Statistical Analysis Systems (SAS) Programming, Study Data Tabulation Model (SDTM).
Sr. Principal Statistics GlobalchannelmanagementSr. Principal StatisticsParamus, New JerseyPrincipal Statistics requires: SAS, ICH guidelines, CDISC data structures, FDA guidelines, SAP preparation, TFL shells, CRF review, database design review, edit check specifications, sample size calculation, analysis dataset validation, CRO oversight. Principal Statistics duties: Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.