Director, Biostatistics

AK America; Cary (NC); On-site; USD 215,000 - 250,000; Full time

Job summary

Asahi Kasei Therapeutics, based in North Carolina, seeks a Director of Biostatistics to lead statistical strategy across clinical programs. You will guide study designs, oversee deliverables, and support regulatory submissions in a dynamic biotech setting.

The role requires deep scientific and regulatory knowledge, strong communication, and the ability to manage multiple studies with CRO partners. Base compensation is $215K–$250K, with compensation influenced by experience and market conditions.

Qualifications

• MSc or PhD in Biostatistics or Statistics.
• 10+ years of clinical trial statistics experience in biotech/pharma.
• Proven leadership across multiple studies or programs.
• Strong working knowledge of regulatory guidelines (ICH, FDA, EMA).
• Expertise in SAS; familiarity with R advantageous.

Responsibilities

• Provide strategic statistical leadership for one or more clinical programs from design to interpretation.
• Oversee statistical sections of protocols, SAPs, and mock TLFs; advise on estimands and endpoints.
• Oversee CROs and external vendors; ensure quality, timelines, and regulatory compliance.
• Collaborate with Data Management to ensure CDISC standards and cross-study data readiness.
• Interpret and present statistical results to clinical, regulatory, and senior leadership.
• Lead statistical components of regulatory submissions (IND/CTA/BLA/MAA) and respond to health authorities.
• Mentor study statisticians and junior team members while collaborating with cross-functional teams.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

Statistical programming

Education

MSc in Biostatistics

PhD in Biostatistics

Tools

SAS

R

Job description

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Materials, Homes, and Health Care , contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Asahi Kasei Therapeutics is the global specialty pharmaceutical business of Asahi Kasei. We are a commercial-stage company committed to positively impacting health by expanding therapeutic options that improve the lives of patients around the world. Drawing upon our strong heritage of scientific innovation, we aim to help reshape care in transplantation, nephrology, immunology, infectious diseases and other underserved conditions.

Job Description:

The Director, Biostatistics is the strategic statistical lead for one or more clinical development programs. This role is responsible for ensuring statistical rigor, consistency, and quality across all studies within a project. Director, Biostatistics partners closely with cross-functional leaders to shape development strategy, guide study designs, oversee statistical deliverables from internal and external partners, and support regulatory submissions.

The position requires deep scientific and regulatory knowledge, strong communication skills, and the ability to lead statistical activities in a dynamic biotech environment.

The base compensation range for this role is $215-250K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

Key Responsibilities

• 1. Program-Level Statistical Leadership 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 the program. Advise on quantitative decision making, including go/no go criteria, dose selection, and adaptive design strategies.
• 2. Study Design & Clinical Development Support Collaborate with Clinical Development to design scientifically sound and efficient clinical trials across phases (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 supporting program objectives.
• 3. Vendor Oversight & Partnership Management Oversee statistical and programming activities conducted by CROs and external vendors across all studies in the project. Ensure deliverables meet quality expectations, timelines, and regulatory standards. Provide clear direction and maintain accountability for outsourced statistical work. Serve as the escalation point for complex statistical issues arising from partner organizations.
• 4. Program-Wide Data Strategy Work with Data Management to ensure data collection standards, CDISC compliance, and data structures are optimized for cross study analysis. Contribute to integrated database planning and integration of external/real world data if applicable. Anticipate data needs for interim analyses, adaptive trials, or regulatory interactions.
• 5. Statistical Analysis & Interpretation Provide clear interpretation and communication of statistical results to clinical, regulatory, and senior leadership stakeholders. Ensure analyses support regulatory strategy, scientific publications, safety evaluations, and internal decision making.
• 6. Regulatory Interaction & Submission Support Lead statistical components of regulatory submissions (e.g., IND, CTA, BLA, MAA). 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.
• 7. Cross Functional Collaboration Actively 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.

Qualifications

• MSc or PhD in Biostatistics, Statistics
• Significant experience (10-15+ years) in clinical trial statistics within biotech/pharma.
• Proven track record of leading statistical activities across multiple studies or programs.
• Strong working knowledge of regulatory guidelines (ICH, FDA, EMA) and statistical principles in drug development.
• Expertise in SAS; familiarity with R is beneficial.
• Excellent communication, leadership, and problem solving skills.
• Ability to balance hands on work with strategic program oversight in a fast paced biotech environment.

Preferred Attributes

• Demonstrated ability to manage CROs an