Daiichi Sankyo, Inc.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.
Daiichi Sankyo, Inc.Director, Early Phase Biostatistics (m/f/d) Daiichi Sankyo, Inc.Director, Early Phase Biostatistics (m/f/d)Basking Ridge, NJMentoring 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.
Daiichi Sankyo, Inc.Associate Director, Biostatistics (Late Stage) Daiichi Sankyo, Inc.Associate Director, Biostatistics (Late Stage)Basking Ridge, NJ$168,000–$252,000 / 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.
Daiichi Sankyo, Inc.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.
Daiichi Sankyo, Inc.Senior Director, Clinical Safety MD Daiichi Sankyo, Inc.Senior Director, Clinical Safety MDBasking Ridge, NJ$275,250–$458,750 / yearFull timeThe individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally.
Daiichi Sankyo, Inc.Manager, Statistical Programming (m/f)d) Daiichi Sankyo, Inc.Manager, Statistical Programming (m/f)d)Basking Ridge, NJDevelop and validate datasets and Tables, Listings, and Figures (TLFs) to ensure high-quality deliverables for pivotal studies, as well as Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS) for oncology regulatory submissions. This role ensures the quality, consistency, and timeliness of deliverables supporting oncology regulatory submissions by guiding programming strategies, reviewing key outputs, and driving issue resolution.
ECLARONewPharmacovigilance (PV) Analytics and Reporting Specialist ECLAROPharmacovigilance (PV) Analytics and Reporting SpecialistLawrenceville, NJResponsibilities:Data Analytics and ReportingBuild and continuously improve data analytics through supporting models that provide insights into efficiency, quality, stakeholder feedback, and key performance indicators to drive timely and informed decision making. The PV Analytics and Reporting Specialist, PV Analytics Center of Excellence applies a combination of life sciences strategy, leadership, and reporting/visualization experience to drive successful servicing of information needs across PS.
Daiichi Sankyo Co LtdDirector, Early Phase Biostatistics Daiichi Sankyo Co LtdDirector, Early Phase BiostatisticsBasking Ridge, NJ$201.84–$302.76Mentoring 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.
Rutgers The State University of New JerseyResearch Teaching Specialist IV (Biostatistics and Epidemiology) Rutgers The State University of New JerseyResearch Teaching Specialist IV (Biostatistics and Epidemiology)New Brunswick, NJCORE VALUES Curiosity and Discovery encouraging an environment of continuous inquiry, creativity, and innovation to generate new knowledge Integrity earning the trust of those we serve and each other through honesty, transparency, accountability, and continuous reflection Collaboration approaching all opportunities with an understanding that together we are better and can achieve more, promoting and maintaining an environment of teamwork and shared knowledge Respect and Caring consistently demonstrating caring compassion and respect through our words and actions Perseverance maintaining an unwavering commitment to our mission, embracing change, overcoming obstacles, and creating and recreating the path to achieve our goals. MISSION Our mission is to accelerate scientific discovery focused on understanding cancer, innovating cancer treatment, and improving cancer prevention to provide outstanding novel and compassionate patient care to provide evidence-based and culturally informed education to physicians, nurses, researchers, staff, and the community, and to achieve cancer health equity in our state through outreach to and engagement of our extraordinarily diverse communities.
Johnson and JohnsonSenior 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.
Penfield Search PartnersAssociate 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.
Regeneron Pharmaceuticals IncSenior Director, Biostatistics - Immunology & Inflammation Regeneron Pharmaceuticals IncSenior Director, Biostatistics - Immunology & InflammationWarren, NJD. 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.
Rutgers The State University of New JerseyAdjunct 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.
Insmed IncDirector, Biostatistics Insmed IncDirector, BiostatisticsBridgewater, NJRemoteTo 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, youll be part of a community that prioritizes the human experience, celebrates curiosity, and values every persons contributions to meaningful progress.
Bristol-Myers Squibb CoNewDirector, 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.
Katalyst Healthcares & Life SciencesSenior 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.
Karwell TechnologiesSenior 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.
Macpower Digital Assets Edge Private LimitedPrincipal Statistician | Senior Principal Biostatistician (W2 Only) Macpower Digital Assets Edge Private LimitedPrincipal Statistician | Senior Principal Biostatistician (W2 Only)Paramus, NJ$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.
Katalyst Healthcares & Life SciencesSr. Statistical Programmer Katalyst Healthcares & Life SciencesSr. Statistical ProgrammerBridgewater, NJGenerate, validate, and/or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications. Extensive knowledge of SAS Macros highly preferred, in addition to knowledge of Base SAS, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
Karwell TechnologiesSr. Statistical Programmer Karwell TechnologiesSr. Statistical ProgrammerBridgewater, NJGenerate, validate, and/or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications. Extensive knowledge of SAS Macros highly preferred, in addition to knowledge of Base SAS, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
R&G US Inc.Statistical Analyst and SAS Programmer R&G US Inc.Statistical Analyst and SAS ProgrammerSomerset, New Jersey$72,000–$72,000Led by former FDA experts and industry experts, R&G US can provide end-to-end services in strategic planning, clinical trial design, statistical analysis, SAS programming, data management, medical writing, medical monitoring, pharmacovigilance, and Data Monitoring Committee services. R&G US's goal is to provide the best service to the clients and work as one team to lower costs, shorten development time, and increase the success probability of products.
Katalyst Healthcares & Life SciencesSenior 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.
Karwell TechnologiesSenior 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.
GlobalchannelmanagementSr. 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.
SystimmuneBiostatistician SystimmuneBiostatisticianPrinceton, NJFull timeYou will work closely with cross-functional teams, including clinical, regulatory, and international colleagues, to contribute to statistical analyses that inform decision-making across the clinical pipeline. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs).
Karwell TechnologiesNewStatistician Karwell TechnologiesStatisticianJersey, NJProvides general infrastructure support to the Department (presents / teaches at the department meetings, contributes to other general department documents or policies, assists with newsletter, helps in department libraries, or trains new hires). Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies.
Katalyst Healthcares & Life SciencesStatistician Katalyst Healthcares & Life SciencesStatisticianNewark, NJProvides general infrastructure support to the Department (presents / teaches at the department meetings, contributes to other general department documents or policies, assists with newsletter, helps in department libraries, or trains new hires). Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies.
GenmabSenior Director, Statistician GenmabSenior Director, StatisticianPrinceton, NJFull timeFor 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. The Role : The Senior Director acts as a high-level statistical expert supporting the clinical development of compounds as therapeutic area lead, compound lead and/or indication lead for both early and late-stage programs and may also act as trial responsible statistician with responsibilities as described below.
TechDigital CorporationC08 - MEDICAL AND REGULATORY AFFAIRS / PHARMACOVIG - PHARMACOVIGILANCE SPECIALIST TechDigital CorporationC08 - MEDICAL AND REGULATORY AFFAIRS / PHARMACOVIG - PHARMACOVIGILANCE SPECIALISTTrenton, NJThe PV Analytics and Reporting Specialist, PV Analytics Center of Excellence contributes to the ongoing development, implementation, and successful execution of the scientific, operational, and regulatory reporting efforts in line with the overall WWPS needs. The PV Analytics and Reporting Specialist, PV Analytics Center of Excellence applies a combination of life sciences strategy, leadership, and reporting/visualization experience to drive successful servicing of information needs across WWPS.
Johnson and JohnsonManager, Observational Health Data Analytics Johnson and JohnsonManager, Observational Health Data AnalyticsRaritan, NJRemoteFull timeCambridge, Massachusetts, United States of America, Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, 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. OHDA's mission is to improve the lives of individuals and quality of healthcare by efficiently generating real-world evidence from the world's observational health data, transparently disseminating evidence-based insights to real-world decision-makers, and objectively advancing the science and technology behind reliable, reproducible real-world analytics.
Pacira Pharmaceuticals, Inc.Associate Director, RWE Analytics Pacira Pharmaceuticals, Inc.Associate Director, RWE AnalyticsParsippany, New Jersey$141,000–$194,000 / yearThe Associate Director is versed in statistical programming languages such as SAS, R, Python, etc. to perform programming in processing data at various levels, verifies analytical datasets, and applies conventional and novel statistical methods to summarize data and generate clinically meaningful results. Working closely with his/her manager, the Associate Director designs pain management studies of clinical/economic burden of diseases, unmet needs of patients, comparative effectiveness of treatments on economic/health outcomes across treatments.
Michael Allen CompanyNewResearch Associate (Remote) Michael Allen CompanyResearch Associate (Remote)Fort Washington, PARemoteTypical engagements include; market identification, sizing and prioritization studies; epidemiology studies; new product uptake and demand forecasting; patient flow and journey analysis; market structure analysis; customer segmentation; account potential and performance evaluation; customer targeting; marketing and sales promotion response measurement; resource allocation modeling; and uncovering marketplace insights. Illustrative data modeling/statistical analyses include general linear models, linear, non-linear and logistic regression analyses; decision tree analysis (CHAID and C&RT); latent class modeling and clustering algorithms; econometric modeling; experimental design and hypothesis testing; ANOVA analysis; survival analysis; time series and forecasting.
GenmabNewAssociate Director, Medical Communications and Publications, HEOR Publications GenmabAssociate Director, Medical Communications and Publications, HEOR PublicationsPlainsboro, NJIn development of a strategic publication plan, the individual will 1) collaborate with cross-functional, key global stakeholders 2) anticipate gaps and identify solutions for publication planning people 3) recognize changes in the healthcare and treatment landscape and adjust publication/communication plans in a timely and efficient manner 4) ensure alignment with broader medical and CORE publication strategies. For 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.