Senior Director Biostatistics (Oncology)
BioNTech SE
15 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
About the role
As Senior Director of Biostatistics, you will represent Statistics in assigned cross-functional clinical study teams and other projects, accountable for all statistical aspects.
Responsibilities:
- Provide statistical guidance for clinical development plans, study protocols, study reports, regulatory submission documents, and publications
- Work in collaborative cross-functional teams
- Perform and/or verify sample size calculations
- Lead development of statistical analysis plans and TLFs; perform and validate statistical analyses
- Plan health authority meetings and prepare associated documents/responses
- Oversee outsourced statistical CRO activities and deliverables (quality and timeliness)
- Support departmental strategies and cross-functional initiatives on standards/infrastructure/processes
- Support GBS Lead in strategy and operations
- Possible line management: recruit, develop, and retain talent
- Guide Statistical Programmers on SDTM/ADaM and TLF specifications and programming
- Provide input to database requirements and partner with Clinical Data Manager to meet data quality standards
Qualifications:
- PhD or Masters in (Bio)Statistics, Mathematics or equivalent
- Minimum 15 years (18 years for Masters) in pharmaceutical industry and/or CRO
- At least 10 years leadership experience overseeing statistics staff (internal/outsourced) in matrix/multidisciplinary environments
- Experience with oncology or infectious disease trials (phase I-IV) and scientific publications
- Experience answering FDA/EMA health authority questions and leading statistics for regulatory submissions (incl. ISE/ISS packages)
- Strong knowledge of clinical development, study designs, advanced statistical methods (adaptive/Bayesian plus), and ICH/FDA/EMA guidelines
- Proficiency in SAS or R and sample size tools (EAST and/or NQuery)
- Deep knowledge of Diagnostics, Biomarkers, PK/PD, PRO, RWE (plus)
Skills:
- Analytical skills; ability to develop realistic plans and risk mitigation strategies
- Excellent communication in English
How to apply:
- Apply via the online form with CV, copy of ID, degree/professional certificates, motivation letter, and contact details.
As Senior Director of Biostatistics, you will represent Statistics in assigned cross-functional clinical study teams and other projects, accountable for all statistical aspects.
Responsibilities:
- Provide statistical guidance for clinical development plans, study protocols, study reports, regulatory submission documents, and publications
- Work in collaborative cross-functional teams
- Perform and/or verify sample size calculations
- Lead development of statistical analysis plans and TLFs; perform and validate statistical analyses
- Plan health authority meetings and prepare associated documents/responses
- Oversee outsourced statistical CRO activities and deliverables (quality and timeliness)
- Support departmental strategies and cross-functional initiatives on standards/infrastructure/processes
- Support GBS Lead in strategy and operations
- Possible line management: recruit, develop, and retain talent
- Guide Statistical Programmers on SDTM/ADaM and TLF specifications and programming
- Provide input to database requirements and partner with Clinical Data Manager to meet data quality standards
Qualifications:
- PhD or Masters in (Bio)Statistics, Mathematics or equivalent
- Minimum 15 years (18 years for Masters) in pharmaceutical industry and/or CRO
- At least 10 years leadership experience overseeing statistics staff (internal/outsourced) in matrix/multidisciplinary environments
- Experience with oncology or infectious disease trials (phase I-IV) and scientific publications
- Experience answering FDA/EMA health authority questions and leading statistics for regulatory submissions (incl. ISE/ISS packages)
- Strong knowledge of clinical development, study designs, advanced statistical methods (adaptive/Bayesian plus), and ICH/FDA/EMA guidelines
- Proficiency in SAS or R and sample size tools (EAST and/or NQuery)
- Deep knowledge of Diagnostics, Biomarkers, PK/PD, PRO, RWE (plus)
Skills:
- Analytical skills; ability to develop realistic plans and risk mitigation strategies
- Excellent communication in English
How to apply:
- Apply via the online form with CV, copy of ID, degree/professional certificates, motivation letter, and contact details.