Senior Director, Biostatistics & Clinical Strategy

Asahi Kasei Therapeutics, Inc.

Cary (NC)

On-site

USD 215,000 - 250,000

Full time

7 days ago

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Job summary

Asahi Kasei Therapeutics, Inc. seeks a Director of Biostatistics to lead statistical strategy across clinical development programs. You will shape study designs, supervise deliverables, and ensure regulatory readiness for submissions.

Strong leadership and communication are essential to align cross-functional teams and CRO partners. You will provide expert statistical oversight, ensuring rigorous analysis and regulatory compliance, while mentoring junior statisticians and driving data-driven

Qualifications

MSc or PhD in Biostatistics or Statistics.
Significant experience (10–15+ years) in clinical trial statistics within biotech/pharma.
Proven track record leading statistical activities across multiple studies or programs.
Strong working knowledge of regulatory guidelines (ICH, FDA, EMA).
Expertise in SAS; familiarity with R is beneficial.

Responsibilities

Serve as the primary statistical lead for one or more clinical development programs.
Guide study design, and oversee statistical deliverables for regulatory submissions.
Oversee CROs and external vendors and ensure quality and timelines.
Work with Data Management and CDISC compliance for cross-study analyses.
Interpret and communicate statistical results to clinical, regulatory, and senior leaders.
Lead regulatory submissions (IND, CTA, BLA, MAA) and respond to health authority questions.
Collaborate across cross-functional teams and mentor junior statisticians.