Director, Biostatistics
About The Position
The Director, Biostatistics is the strategic statistical lead for one or more clinical development programs, ensuring statistical rigor, consistency, and quality across all studies within a project. The role partners with cross-functional leaders to shape development strategy, guide study designs, oversee statistical deliverables from internal and external partners, and support regulatory submissions. It requires deep scientific and regulatory knowledge, strong communication skills, and the ability to lead statistical activities in a dynamic biotech environment. Asahi Kasei Therapeutics is the global specialty pharmaceutical business of Asahi Kasei. It is a commercial-stage company focused on expanding therapeutic options in transplantation, nephrology, immunology, infectious diseases, and other underserved conditions.
Requirements
- MSc or PhD in Biostatistics or Statistics.
- 10–15+ years of experience in clinical trial statistics within biotech or pharmaceutical companies.
- Proven track record of leading statistical activities across multiple studies or programs.
- Strong working knowledge of ICH, FDA, and EMA regulatory guidelines and statistical principles in drug development.
- Expertise in SAS.
- Excellent communication, leadership, and problem-solving skills.
- Ability to balance hands-on work with strategic program oversight in a fast-paced biotech environment.
Nice To Haves
- Familiarity with R.
- Experience managing CROs and external statistical partners.
- Experience with adaptive or innovative designs.
- Exposure to early-stage development or rare or complex diseases.
- Ability to influence senior stakeholders and drive strategic decisions.
- Strong collaboration mindset and high attention to scientific and operational quality.
- Experience using real-world data to support programs.
- Experience collaborating with Medical Affairs.
Responsibilities
- Serve as the primary statistical point of contact for one or more clinical development programs.
- Provide strategic input into clinical development plans, target product profiles, and overall program strategy.
- Ensure statistical consistency and alignment across all clinical studies in a program.
- Advise on quantitative decision making, including go/no-go criteria, dose selection, and adaptive design strategies.
- Collaborate with Clinical Development to design scientifically sound and efficient clinical trials from first-in-human through registration.
- Oversee and review statistical sections of study protocols, statistical analysis plans (SAPs), and mock tables, listings, and figures (TLFs).
- Recommend statistical methodologies, estimands, and endpoints that support program objectives.
- Oversee statistical and programming activities conducted by CROs and external vendors across project studies.
- Ensure external deliverables meet quality expectations, timelines, and regulatory standards; provide direction and accountability for outsourced statistical work.
- Serve as the escalation point for complex statistical issues from partner organizations.
- Work with Data Management on data collection standards, CDISC compliance, and data structures optimized for cross-study analyses.
- Contribute to integrated database planning and integration of external or real-world data when applicable.
- Anticipate data needs for interim analyses, adaptive trials, and regulatory interactions.
- Interpret and communicate statistical results to clinical, regulatory, and senior leadership stakeholders.
- Ensure analyses support regulatory strategy, scientific publications, safety evaluations, and internal decision making.
- Lead statistical components of regulatory submissions, including IND, CTA, BLA, and MAA submissions.
- Prepare statistical responses to health authority questions and attend regulatory meetings as the statistical representative.
- Ensure compliance with ICH guidelines, regulatory expectations, and best practices in clinical statistics.
- Contribute to cross-functional development teams, safety review committees, and governance meetings.
- Translate complex statistical concepts into clear, actionable insights for non-statisticians.
- Provide mentorship and guidance to study statisticians and junior team members.
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What This Job Offers
Job Type
Full-time
Career Level
Director
