Director Biostatistics (Oncology)

Role Summary

Director Biostatistics (Oncology) oversees statistical leadership for assigned clinical trials and programs, collaborates with development partners to harmonize standards, and represents Statistics in cross-functional teams. Responsible for statistical aspects across partner-sponsored studies and IITs.

Responsibilities

• Provide statistical support and leadership for assigned clinical trials and programs in accordance with company objectives.
• Oversee and give statistical guidance on trials within a program or platform.
• Train and guide colleagues as an SME in topics like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, or RWE/epidemiology.
• Provide statistical input into clinical development plans, protocols, study reports, regulatory submissions, and publications ensuring accurate deliverables.
• Perform and/or verify sample size calculations; lead development of SAPs and TLFs; perform analyses and validate results.
• Participate in planning for health authority meetings and prepare associated documents and responses.
• Oversee outsourced statistical CRO activities and deliverables ensuring high quality and timeliness.
• Provide input to database requirements and collaborate with Clinical Data Manager to ensure data quality standards.
• Guide Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming.
• Serve as lead contact in Biostatistics for external partners on assigned studies.
• Support initiatives to develop, implement and improve standards, processes and infrastructure.
• Keep updated on development of new statistical methodologies and technologies.
• Mentor Associate Directors or less experienced Directors; may assume line management responsibilities and recruit/develop/retain talent.

Qualifications

• PhD or Masters in (Bio)Statistics, Mathematics or equivalent.
• Minimum 8 years (10 years for masters) in the pharmaceutical industry and/or CRO.
• At least 5 years of work/leadership experience, overseeing statistics staff and representing Biostatistics in a matrix organization and multidisciplinary teams.
• Experience in planning, conducting and analyzing oncology trials from phase I-IV, including scientific publications.
• Experience supervising outsourced activities and developing/executing outsourcing strategies.
• Strong knowledge of clinical development, study designs, and advanced statistical methods (adaptive design and/or Bayesian is a plus); familiarity with regulatory guidelines (ICH, FDA, EMA).
• Strong knowledge of statistical analysis software (SAS and/or R) and sample size software (e.g., EAST and/or NQuery).
• Deep understanding of topics like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, RWE/epidemiology (a plus).
• Excellent analytical, communication, and interpersonal skills; ability to work in a fast-paced environment.

Skills

• Analytical thinking and problem solving
• Advanced statistical methods and study design
• Statistical programming (SAS, R) and sample size calculations
• Regulatory knowledge (ICH, FDA, EMA)
• Leadership and mentorship

Education

• PhD or Masters in (Bio)Statistics, Mathematics or equivalent