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, 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.
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.
Senior Biostatistician Canfield Scientific, Inc.Senior BiostatisticianParsippany-Troy Hills, NJ$120,000–$160,000 / yearFull timeThe position requires strong technical expertise in statistics and SAS programming, with the ability to independently develop Statistical Analysis Plans (SAPs), execute and validate statistical analyses, and prepare statistical components of clinical study reports (CSRs). The right candidate can translate statistical outputs into clinically meaningful interpretations and communicate findings clearly to both technical and non-technical audiences.
Biostatistician JouléBiostatisticianJersey City, NJ$60–$65 / hourWe are seeking a detail-oriented and analytical Clinical Biostatistician (Consultant) to provide statistical support for clinical studies involving medical devices. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
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 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).
Principal 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.
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, 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.
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.
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 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 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.
Principal 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.
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 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.
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.
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.
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.
Clinical Principal, Biostatistician, Roivant Health Roivant Sciences IncClinical Principal, Biostatistician, Roivant HealthNY$130,000–$220,000 / yearIn six years since inception, we've created eight enduring companies and over $1B in enterprise value, including the leading deidentified healthcare data exchange platform (Datavant) and a top-tier computational drug discovery company (VantAI) which has partnered with Johnson & Johnson, Bristol-Myers Squibb, and Boehringer Ingelheim. Five new medicines have been approved off the Roivant platform, we''ve built multiple biotechs that have become public companies, and we''ve created substantial value across the platform spanning computational drug discovery, healthcare data exchange, and novel therapeutic platforms.
NewPrincipal Statistician | Senior Principal Biostatistician (W2 Only) Macpower Digital Assets Edge Private LimitedPrincipal Statistician | Senior Principal Biostatistician (W2 Only)Paramus, NJRemote$60–$66 / hourJob Summary: The Senior Manager Statistics will be responsible for statistical activities across all stages of clinical trials, from protocol development through final study reporting. Key Responsibilities: Review clinical trial protocols and contribute to the design of study elements, including sample size calculations , statistical methodology, and timelines.
Director, Global Epidemiology & Real-World Evidence Shionogi Inc.Director, Global Epidemiology & Real-World EvidenceFlorham Park, New Jersey$230,000–$265,000 / yearThis role provides scientific and methodological leadership for observational research and evidence generation, partners cross-functionally to integrate RWE into development and medical strategies, and oversees key vendor relationships and external collaborations. Overview: The Director, Global Epidemiology & Real-World Evidence leads epidemiology and RWE activities across assigned therapeutic areas, with a strong focus on the U.S., in alignment with global strategy.
Director, Global Epidemiology & Real World Evidence Shionogi & Co LtdDirector, Global Epidemiology & Real World EvidenceFlorham Park, NJ$230,000–$265,000 / yearThis role provides scientific and methodological leadership for observational research and evidence generation, partners cross-functionally to integrate RWE into development and medical strategies, and oversees key vendor relationships and external collaborations. The Director, Global Epidemiology & Real-World Evidence leads epidemiology and RWE activities across assigned therapeutic areas, with a strong focus on the U.S., in alignment with global strategy.
Vice President, Pharmacovigilance & Risk Management Celldex Therapeutics IncVice President, Pharmacovigilance & Risk ManagementNJ$308,977–$401,269 / yearThe Vice President, Pharmacovigilance & Risk Management will provide strategic and operational leadership for Celldex's global pharmacovigilance and risk management function across the product lifecycle, from clinical development through commercialization. Reporting to the SVP, Chief Medical Officer, this individual will serve as the company's senior safety leader, responsible for the oversight, evolution, and execution of all pharmacovigilance activities, ensuring compliance with global regulatory requirements while proactively identifying, evaluating, and managing product safety risks.
Principal Biostatistician (Remote) Everest Clinical ResearchPrincipal Biostatistician (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 Biostatisticians 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. Provide statistical oversight on projects in the assigned drug development programs/projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting.
Senior Biostatistician Everest Clinical ResearchSenior BiostatisticianNew JerseyTo 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 Biostatisticians 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. Lead statistical dry runs and final run by actively participating or contributing to project and resources management, addressing statistical and programming questions and interacting with data management to follow up and resolve data issues.
Adjunct Faculty, Department of Health and Human Performance *Multiple Disciplines Available* Kean UniversityAdjunct Faculty, Department of Health and Human Performance *Multiple Disciplines Available*Union, New JerseyEmployment at Kean requires working at any of our New Jersey campus locations or affiliated work sites, which may include, but not be limited to: the main campus in Union; Kean Ocean in Toms River; Kean Skylands in Jefferson Township; Kean Jersey City; Kean at Brookdale in Middletown Township; Manahawkin; Princeton; and Trenton. Recreation Administration (Sport and Event Management) – to teach courses in the areas of Sport and Event Management, including Introduction to Sport and Event Management, Legal Aspects of Recreation, sport and Event, Financial Aspects of Recreation, Sport and Event, Event Management, and Sport Promotion and Sponsorship in-person at the Union or Kean Ocean campus.
Senior Director, Real World Data & Analytics Revolution Medicines IncSenior Director, Real World Data & AnalyticsNYRemote$244,000–$305,000 / yearOversee high-quality RWE study design, protocol development, statistical analysis planning, and final reporting in support of regulatory submissions and product value evidence - typical projects include include systematic literature reviews, natural history studies, clinical trial design and optimization, comparative effectiveness and safety, and healthcare resource utilization types of studies, post-approval safety studies leveraging RWD, as well as RWD-related insights such as quick feasibility and information used to inform our fast-moving clinical programs. The Opportunity: The Senior Director, Real-World Analytics & Programming will work with the Executive Director, Head of Epidemiology and RWD Strategy and VP of HEOR/RWE to establish Real-World Analytics and Programming capabilities at RevMed by leading the execution of key Real-World Analytics and Programming deliverables for RevMed assets.