Director, Biostatistics & Clinical Strategy

Asahi Kasei Bioprocess America, Inc.; United States; On-site; USD 215,000 - 250,000; Full time

Job summary

Asahi Kasei Therapeutics seeks a Director of Biostatistics to lead statistical strategy across clinical development programs. You will partner with cross-functional teams to shape study designs, ensure regulatory-compliant analyses, and oversee deliverables from internal and external partners.

The role requires deep regulatory knowledge (ICH/FDA/EMA), a strong track record in biotech/pharma statistics, and excellent leadership and communication to guide decisions at senior levels.

Qualifications

• 10–15+ years in clinical trial statistics within biotech/pharma.
• Proven track record leading statistical activities across multiple studies or programs.
• Strong knowledge of regulatory guidelines (ICH, FDA, EMA).
• Excellent communication, leadership, and problem-solving skills.

Responsibilities

• Provide program-level statistical leadership for one or more development programs.
• Oversee design, SAPs, and mock TLFs for individual studies.
• Oversee CROs and external vendors; ensure quality and timelines.
• Contribute to data strategy and cross-study analyses with CDISC standards.
• Interpret results for leadership; support regulatory strategy and publications.
• Lead statistical components of regulatory submissions and responses.
• Mentor statisticians and collaborate with cross-functional teams.

Skills

Statistical leadership

Clinical trials statistics

Regulatory knowledge

SAS

Leadership

Communication

Education

MSc or PhD in Biostatistics

Tools

SAS

R

Job description

Asahi Kasei Therapeutics seeks a Director of Biostatistics to lead statistical strategy across clinical development programs. You will partner with cross-functional teams to shape study designs, ensure regulatory-compliant analyses, and oversee deliverables from internal and external partners.

The role requires deep regulatory knowledge (ICH/FDA/EMA), a strong track record in biotech/pharma statistics, and excellent leadership and communication to guide decisions at senior levels.