Director of Biostatistics & Clinical Strategy

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

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.