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.
Research Scholar, Biostatistics Service, Department of Epidemiology and Biostatistics Memorial Sloan Kettering Cancer CenterResearch Scholar, Biostatistics Service, Department of Epidemiology and BiostatisticsNew York, New YorkThe successful candidate will have the opportunity to lead the development of novel statistical and computational methods for integrating multimodal datasets to uncover mechanisms of treatment response, identify predictive biomarkers, and advance precision immuno-oncology. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it.
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.
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).
Biostatistics Research Associate Artera IncBiostatistics Research AssociateNYRemote$35–$45 / hourThis is a hands-on, project-based role working with real-world clinical datasets and contributing to analyses that support AI model development, clinical validation, regulatory submissions, publications, conference abstracts, collaborator updates, and internal decision-making. You will work closely with biostatisticians, data analysts, machine learning scientists, clinical operations, medical affairs, regulatory, and product teams to support statistical analyses and data workflows for high-priority oncology programs.
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.
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.
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.
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).
Senior Manager/Associate Director, Biostatistics Rapport Therapeutics IncSenior Manager/Associate Director, BiostatisticsNew York, NY$200,000–$220,000 / yearOversee the production of protocol development (study design, endpoint selection, sample size calculation and statistical methods) and Statistical Analysis Plan (SAP) that lead to comprehensive clinical study reports suitable for regulatory submissions. Your impact: Rapport is seeking a Senior Manager / Associate Director of Biostatistics who will have a hands-on role in shaping the design, analysis, and interpretation of clinical trial data for our Bipolar Mania program.
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.
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, 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 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.
Director, Biostatistics TempusDirector, BiostatisticsNew York City, NY$180,000–$240,000 / yearWe 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. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
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.
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.
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.
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.