Senior Manager, Biostatistics
Genmab
August 06, 2026
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
The Senior Manager, Biostatistics acts as a biostatistician supporting clinical development of compounds (as compound lead to proof of concept) and/or as trial responsible statistician.
Responsibilities
- Compound/Indication level: Lead Statistics for designated compound/indication; advise on new biostatistics methodologies; engage with regulatory authorities; ensure consistency of statistical methods and data handling across trials; share compound/indication statistical work with involved biostatisticians and vendor; support integrated database specification.
- CDT member: Provide statistical input to CDT strategy and synopsis development; advise on trial design and analyses (incl. advanced statistical methods); drive design/synopsis with stakeholders; represent CDT/company at regulatory and KOL/network/partner meetings; ensure transparent stakeholder communication; plan and conduct integrated analyses using integrated databases to support decisions/submissions/marketing; support scientific input for presentations/posters/articles.
- Trial/CTT member: Represent Biostatistics at meetings/congresses; engage regulators; facilitate lessons learned; review partner synopsis/protocols/SAPs/results presentations/clinical trial reports; coordinate data transfers with programmer/data manager; review protocol/amendments; vendor oversight; input to eCRF/validation/DSUR/IB tables-figures-listings; review assay validation; exploratory/ad hoc analyses and modeling; review/approve randomization and stratification; UAT IRT randomization; ensure blinding procedures; deliver stats outputs; plan trial result meetings; review/approve CSR; support regulatory filing.
Requirements
- MS/PhD or equivalent in a statistical discipline.
- 5+ years relevant experience (preferred) or demonstrated capability.
- Experience with statistical analysis, modeling/simulation, and adaptive trial designs.
- Clinical trials experience; oncology preferred.
- Proficient with SAS or similar statistical software.
- Excellent oral/written communication; independent and team work; confident, proactive, quick learner; prioritize in fast-paced changing environments.
Benefits (US, within first year for regular full-time employees)
- 401(k): 100% match on first 6%; health (2 options incl. HDHP/HSA), dental, vision; voluntary critical illness/accident/hospital indemnity; paid vacation/sick/holidays + 12 weeks discretionary paid parental leave; backup care and family support, financial wellness tools, emotional well-being support; commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Salary band (US)
- $130,560–$195,840.
Responsibilities
- Compound/Indication level: Lead Statistics for designated compound/indication; advise on new biostatistics methodologies; engage with regulatory authorities; ensure consistency of statistical methods and data handling across trials; share compound/indication statistical work with involved biostatisticians and vendor; support integrated database specification.
- CDT member: Provide statistical input to CDT strategy and synopsis development; advise on trial design and analyses (incl. advanced statistical methods); drive design/synopsis with stakeholders; represent CDT/company at regulatory and KOL/network/partner meetings; ensure transparent stakeholder communication; plan and conduct integrated analyses using integrated databases to support decisions/submissions/marketing; support scientific input for presentations/posters/articles.
- Trial/CTT member: Represent Biostatistics at meetings/congresses; engage regulators; facilitate lessons learned; review partner synopsis/protocols/SAPs/results presentations/clinical trial reports; coordinate data transfers with programmer/data manager; review protocol/amendments; vendor oversight; input to eCRF/validation/DSUR/IB tables-figures-listings; review assay validation; exploratory/ad hoc analyses and modeling; review/approve randomization and stratification; UAT IRT randomization; ensure blinding procedures; deliver stats outputs; plan trial result meetings; review/approve CSR; support regulatory filing.
Requirements
- MS/PhD or equivalent in a statistical discipline.
- 5+ years relevant experience (preferred) or demonstrated capability.
- Experience with statistical analysis, modeling/simulation, and adaptive trial designs.
- Clinical trials experience; oncology preferred.
- Proficient with SAS or similar statistical software.
- Excellent oral/written communication; independent and team work; confident, proactive, quick learner; prioritize in fast-paced changing environments.
Benefits (US, within first year for regular full-time employees)
- 401(k): 100% match on first 6%; health (2 options incl. HDHP/HSA), dental, vision; voluntary critical illness/accident/hospital indemnity; paid vacation/sick/holidays + 12 weeks discretionary paid parental leave; backup care and family support, financial wellness tools, emotional well-being support; commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Salary band (US)
- $130,560–$195,840.