Associate Director, Biostatistics (Late Stage Oncology) Daiichi Sankyo, Inc.Associate Director, Biostatistics (Late Stage Oncology)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. 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.
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.
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).
Executive Director, Head of Biostatistics KardiganExecutive Director, Head of BiostatisticsPrinceton, New Jersey$274,000–$363,000 / yearServe as a trusted scientific and strategic partner to Clinical Development, Medical, Regulatory Affairs, and executive leadership, providing data-driven guidance on program strategy, statistical risk, trial feasibility, and critical portfolio decisions. · Lead regulatory statistical strategy and serve as the primary statistical representative in interactions with FDA and other health authorities, including briefing packages, regulatory meetings, submission support, and responses to agency inquiries.
Manager, Biostatistics Pacira Pharmaceuticals, Inc.Manager, BiostatisticsParsippany, New Jersey$102,000–$140,000 / yearFull timeThe range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications. Support interactions with regulatory authorities on statistical topics, including participation in meetings, responses to information requests, development of preparation materials and briefing book materials for meetings and communications with regulatory authorities.
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 Scientist, Biostatistics Merck & Co IncSenior Scientist, BiostatisticsRahway, NJ$117,000–$184,200 / yearMust demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development; and possess the ability to learn, be proactive and motivated, and consistently focus on details and execution. Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
Director, Biostatistics AltimmuneDirector, BiostatisticsMorristown, NJFull timeJob Requirements (Essential knowledge, skills, and attributes):PhD in Statistics, Biostatistics, or related field with 7+ years of clinical trial statistics experience in biotech/pharma; or MS with 10+ years of equivalent industry Strong knowledge of statistical methods relevant to clinical trials, including longitudinal data, survival analysis, and Bayesian approaches. The Company's lead candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD).
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.
Director Biostatistics Genmab ASDirector 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.
Senior Manager, Biostatistics Genmab ASSenior Manager, 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.
Senior Manager, Biostatistics Eikon Therapeutics, Inc.Senior Manager, BiostatisticsJersey City, NJ$170,000–$204,750 / yearThis candidate excels in leading interdisciplinary teams to design studies, developing statistical analysis plans, performing advanced statistical analyses, and providing guidance to team members. Qualifications: PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years of clinical research and drug development experience, or a Master's degree with a minimum of 7 years relevant work experience.
Associate Director Biostatistics Integrated Resources, IncAssociate Director BiostatisticsWoodcliff Lake, New JerseyFull timeExperience contributing to sensitivity analysis for missing data, longitudinal data analysis and statistical modeling diagnostics Experience with Bayesian study designs is an added advantage Excellent interpersonal skills in project management, collaboration and communication to leadership, Study Directors, Data Management, Statistical Programming and other clinical development team members, colleagues, CROs, and external collaborators Must be flexible to work in a dynamic environment where multi-tasking and changing priorities exist Must possess strong analytical skills in addition to demonstrated problem solving and risk mitigation skills Recognized in the profession as a dedicated professional with a strong work ethic Must be a self-sufficient, highly motivated, highly organized, and proactive individual who is a quick learner. Responsibilities include but are not limited to: Reviewing whole protocols and interfacing with clinicians and other functions to understand study requirements and design study elements including sample size calculations, analysis methods, study duration, etc. for multiple studies.
Senior Manager, Biostatistics Eikon Therapeutics IncSenior Manager, BiostatisticsJersey City, NJ$170,000–$204,750 / yearEikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. This candidate excels in leading interdisciplinary teams to design studies, developing statistical analysis plans, performing advanced statistical analyses, and providing guidance to team members.
Associate Director, Late Phase Research Biostatistics Pacira Pharmaceuticals, Inc.Associate Director, Late Phase Research BiostatisticsParsippany, New Jersey$141,000–$194,000 / yearFull timeMinimum 5 years of hands on Biostatistics experience in the Pharmaceutical or Biotech industry; Minimum 3 years’ experience managing and implementing working relationships with external agencies, such as CRO, consultant groups, and research committees. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.
Senior Manager, Biostatistics Integrated Resources, IncSenior Manager, BiostatisticsWoodcliff Lake, New JerseyFull timeThe study statistician will be accountable for supporting protocol development and study initiation, developing SAP, TLG shells, specification of variable derivation, SQS plan and DMC charter, providing statistical and validation support for analysis datasets, statistical TLGs, performing and validating statistical analysis, independently reviewing CSRs and performing data interpretation, supporting preparation of inputs for regulatory documents, drafting responses to health authorities including execution of new analysis required for responses, and managing CROs. The Senior Manager, Biostatistics - Neuroscience will be expected to work independently with minimal supervision, serving as study statistician for clinical studies.
NewDirector, Biostatistics PharmaronDirector, BiostatisticsFranklin Township, NJ$165,000–$180,000 / yearFull timeAuthoring and review of statistical analysis plans, statistical reports and statistical methodology sections in clinical protocols and reports in different therapeutic areas from phase I to phase IV.Attend the regular department operational and management meetings, meets regularly with VP to discuss staffing for upcoming studies and department development strategies. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products.
NewAssociate Director, Biostatistics PharmaronAssociate Director, BiostatisticsFranklin Township, NJ$145,000–$160,000 / yearFull timePosition: Associate Director, BiostatisticsSalary Range: $145K-$160K Location: Sommerset, NJ (Hybrid or Remote)About PharmaronPharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products.
Remote Biostatistics Consultant – Oncology Program GlobalchannelmanagementRemote Biostatistics Consultant – Oncology ProgramNewark, New JerseyRemoteTo land this role and help us maintain an exceptionally high bar for scientific validity, you must possess the following elite skills and background: Professional Experience: A minimum of 3 years of post-PhD experience or 5 years of post-MS experience directly managing and executing statistical analyses within clinical trials. You will work at the intersection of clinical data and medical communications, collaborating closely with the Medical Strategy Lead and Publications Specialist to turn complex clinical trial data into high-impact, accurate scientific content.
Associate Director, Biostatistics Pharmaron Beijing Co LtdAssociate Director, BiostatisticsFranklin Township, NJ$145,000–$160,000 / yearFounded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. The Associate Director will also provide expert statistical guidance on study design, protocol and CRF development, sample size calculations, statistical analysis plans, and clinical study reports, serving as a trusted advisor to clients and cross-functional teams.