Director Biostatistics (Oncology)

Role Summary

Director Biostatistics (Oncology) responsible for collaborating with strategic clinical development partners to harmonize statistical analysis standards, review stats-related documents for partner-sponsored studies, oversee IIT studies, and represent Statistics in cross-functional teams, accountable for all statistical aspects.

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 GBS colleagues as an SME in topics such as Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, or RWE/epidemiology.
• Provide statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables.
• Perform and/or verify sample size calculations. Lead development of statistical analysis plans and TLFs; perform statistical analyses and validate analysis results.
• Participate in planning for health authority meetings, development of associated documents, and preparation of responses.
• Oversee outsourced statistical CRO activities and deliverables ensuring highest quality and timely delivery.
• Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met.
• Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming.
• Serve as lead contact person in Biostatistics for external partners for assigned studies.
• Support and participate in 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 and assume line management responsibilities where applicable, including recruiting, developing, and retaining 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 (internal and outsourced) and representing Biostatistics in a matrix organization and multidisciplinary teams.
• Experience in planning, conducting and analyses of oncology trials from phase I–IV, including scientific publications.
• Experience in supervision of outsourced activities and development/execution of outsourcing strategies.
• Strong knowledge of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a plus), regulatory guidelines (ICH, FDA, EMA).
• Strong knowledge of statistical analysis software (SAS and/or R) and sample size calculation software (e.g., EAST and/or NQuery).
• Deep understanding of topics like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, RWE/epidemiology is a plus.
• Excellent analytical skills and ability to communicate complex analyses to cross-functional colleagues.
• Excellent interpersonal skills and teamwork abilities.
• Ability to thrive in a fast-paced environment; proactive, resourceful, and efficient.
• Excellent written and spoken English.

Education

• As listed in Qualifications (PhD or Masters in related field).