Director, Biostatistics

Asahi Kasei • Cary, NC

2d • $215,000 - $250,000 • Hybrid

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.

The position includes program-level statistical leadership; clinical trial design and development support; oversight of CRO and vendor statistical and programming work; program-wide data strategy; analysis and interpretation of results; regulatory interaction and submission support; and cross-functional collaboration, including mentorship of study statisticians and junior team members.

Requirements

• MSc or PhD in Biostatistics or Statistics.
• 10–15+ years of experience in clinical trial statistics within biotech or pharma.
• Proven track record of leading statistical activities across multiple studies or programs.
• Strong working knowledge of regulatory guidelines, including ICH, FDA, and EMA, 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.
• Demonstrated ability to manage 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 across phases, from First in Human through registration.
• Provide oversight and review of statistical sections of protocols, SAPs, and mock TLFs for individual studies.
• Recommend appropriate statistical methodologies, estimands, and endpoints to support program objectives.
• Oversee statistical and programming activities conducted by CROs and external vendors across project studies.
• Ensure vendor deliverables meet quality expectations, timelines, and regulatory standards; provide direction and maintain accountability for outsourced statistical work.
• Serve as the escalation point for complex statistical issues arising from partner organizations.
• Work with Data Management on data collection standards, CDISC compliance, and data structures optimized for cross-study analysis.
• Contribute to integrated database planning and integration of external or real-world data, if applicable.
• Anticipate data needs for interim analyses, adaptive trials, or 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, such as 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.

Benefits

• Base compensation range of $215,000–$250,000

What This Job Offers

• Job Type: Full-time
• Career Level: Director