Senior Biostatistics Director, Clinical Programs

Bionova Scientific LLC; Cary (NC); Hybrid; USD 215,000 - 250,000; Full time

Job summary

Asahi Kasei Therapeutics in North Carolina (Cary) seeks a Director, Biostatistics to lead strategic statistical activities across clinical development programs. You will shape study designs, guide regulatory submissions, and collaborate with cross-functional teams to drive rigorous, compliant analyses in a fast-paced biotech environment.

The role emphasizes regulatory knowledge (ICH/FDA/EMA), strong communication, and mentorship of junior statisticians. Hybrid work options are available.

Qualifications

• Advanced degree in biostatistics or statistics with 10–15+ years in clinical trial statistics.
• Proven leadership across multiple studies or programs in biotech/pharma.
• Deep knowledge of regulatory guidelines (ICH, FDA, EMA) and drug development.
• Strong communication and collaboration across cross-functional teams.

Responsibilities

• Provide strategic statistical leadership for clinical development programs.
• Guide study design, estimands, endpoints, and adaptive design strategies.
• Oversee statistical sections of protocols, SAPs, and TLFs.
• Lead regulatory submissions and responses to health authorities.

Skills

Statistical leadership

Regulatory submissions

ICH FDA EMA knowledge

SAS

R familiarity

Communication

Mentorship

Education

MSc or PhD in Biostatistics

Tools

SAS

R

Job description

Asahi Kasei Therapeutics in North Carolina (Cary) seeks a Director, Biostatistics to lead strategic statistical activities across clinical development programs. You will shape study designs, guide regulatory submissions, and collaborate with cross-functional teams to drive rigorous, compliant analyses in a fast-paced biotech environment.

The role emphasizes regulatory knowledge (ICH/FDA/EMA), strong communication, and mentorship of junior statisticians. Hybrid work options are available.