Director Biostatistics (Oncology)

As Director of Biostatistics, you lead statistical input across clinical study teams and programs, owning statistical deliverables and regulatory inputs. You will serve as a biostatistics lead on cross-functional teams, shaping clinical development plans, protocols, reports, and submissions. You manage outsourced CRO activities, mentor staff, and help set departmental standards. This role offers impact on oncology/infectious disease programs and health authority interactions, within a collaborative, performance-driven environment.

• annual bonus
• equity
• health benefits
• wellbeing support
• career development
• global mobility options

• Collaborate in cross-functional teams
• Perform and/or verify sample size calculations
• Lead development of SAPs and TLFs, perform analyses and validate results
• Plan for health authority meetings and prepare responses
• Oversee outsourced statistical CRO activities for quality and timeliness
• Support development of departmental strategies and cross-functional initiatives
• Assume line management responsibilities and recruit/develop talent
• Guide Statistical Programmers on SDTM/ADaM and TLFs specifications
• Provide input to database requirements and ensure data quality with Clinical Data Management

• PhD or Masters in (Bio)Statistics, Mathematics or equivalent
• Minimum 10 years in pharma/CRO (13 years for Masters)
• At least 5 years of leadership experience managing statistics staff and cross-functional representation
• Experience in planning, conducting and analyzing oncology or infectious disease trials (Phase I–IV) and publications
• Experience addressing health authority questions and regulatory submissions (ISE/ISS)
• Strong knowledge of clinical development, study designs, and advanced statistical methods (adaptive design and/or Bayesian is a plus)
• Proficient in SAS or R; experience with sample size software (EAST and/or NQuery)
• Knowledge of Diagnostics, Biomarker, PK/PD, PRO, RWE is a plus
• Excellent analytical and communication skills, English proficiency

• collaboration
• clear communication of complex analyses
• high-quality, timely delivery
• SAS
• R
• adaptive design