As Director Biostatistics (Oncology), you will collaborate with strategic clinical development partners and oversee/coordinate the collaborated IIT studies. You will also train and guide GBS colleagues, provide statistical input into clinical development plans, and perform and/or verify sample size calculations.
Requirements
- 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 in representing Biostatistics in a matrix organization and in a multidisciplinary team
- Experiences in planning, conducting and analyses of oncology trials from phase I-IV, including scientific publications
- Experience in supervision of outsourced activities as well as with the development and execution of outsourcing strategies
- Very good knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus), regulatory guidelines (ICH, FDA, EMA)
- Very good knowledge of statistical analysis software (SAS and/or R) and sample size calculation software (e.g., EAST and/or NQuery)
- Deep understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, RWE/epidemiology, is a plus
Benefits
- Medical, Dental and Vision Insurance
- Life, AD&D, Critical Illness Insurance
- Pre-tax HSA & FSA, DCRA Spending Accounts
- Employee Assistance & Concierge Program (EAP) available 24/7
- Parental and Childbirth Leave & Family Planning Assistance
- Sitterstream: Virtual Tutoring & Childcare Membership
- Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
- 401(K) Plan with Company Match
- Tuition Reimbursement & Student Loan Assistance Programs
- Wellbeing Incentive Platforms & Incentives
- Professional Development Programs
- Commuting Allowance and subsidized parking
- Discounted Home, Auto & Pet Insurance