Director, Biostatistics — Hybrid & Global Programs

Celgard; Cary (NC); Hybrid; USD 215,000 - 250,000; Full time

Job summary

Asahi Kasei Therapeutics in the United States seeks a Director of Biostatistics to provide strategic statistical leadership across clinical programs. You will guide study designs, ensure regulatory quality, and collaborate with cross-functional teams in a fast-paced biotech environment.

The role requires advanced biostatistics expertise, strong communication, and the ability to manage external vendors while aligning with regulatory expectations.

Qualifications

• MSc or PhD in Biostatistics, 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 is beneficial.
• Excellent communication, leadership, and problem solving skills.

Responsibilities

• Provide strategic statistical leadership for one or more clinical development programs.
• Shape development plans, target product profiles, and overall program strategy.
• Oversee statistical sections of protocols, SAPs, and mock TLFs.
• Oversee statistical activities conducted by CROs and external vendors; ensure quality and timelines.
• Work with Data Management to ensure CDISC compliance and cross-study data integration.
• Lead statistical components of regulatory submissions and respond to health authority questions.

Skills

Leadership & mentoring

Cross-functional collaboration

Statistical leadership

Regulatory statistics

Data strategy & CDISC

Education

MSc or PhD in Biostatistics/Statistics

Tools

SAS

R

Job description

Asahi Kasei Therapeutics in the United States seeks a Director of Biostatistics to provide strategic statistical leadership across clinical programs. You will guide study designs, ensure regulatory quality, and collaborate with cross-functional teams in a fast-paced biotech environment.

The role requires advanced biostatistics expertise, strong communication, and the ability to manage external vendors while aligning with regulatory expectations.