Senior Director, Biostatistics & Clinical Development

AskBio Inc.; Durham (NC); Hybrid; USD 180,000 - 240,000; Full time

Job summary

AskBio Inc., a Bayer subsidiary, seeks a Senior Director, Biostatistics to lead statistical strategy across non-clinical, CMC, and clinical programs. You will supervise statisticians, ensure rigorous study design, analysis, and reporting, and partner with cross-functional teams to advance gene therapy programs.

You will collaborate with regulatory authorities (FDA/EMA) and guide submissions while maintaining up-to-date knowledge of statistical methods and drug development guidelines.

Qualifications

• Senior/lead biostatistics role with strategic impact.
• Experience partnering with FDA/EMA and other regulators.
• Strong track record in design, analysis, and reporting of trials.

Responsibilities

• Provide technical leadership for clinical development programs.
• Oversee statistical analyses, SAPs, and clinical study reports.
• Mentor statisticians, programmers, and data managers.
• Coordinate with CROs and external statistical consultants.
• Represent Biostatistics in regulatory interactions and submissions.
• Develop standards and SOPs; ensure high-quality deliverables.

Skills

Statistical leadership

Clinical trial design

Regulatory strategy

Cross-functional leadership

Education

PhD in Biostatistics or related field

MD/PhD considered a plus

Tools

SAS

R

Python

Job description

AskBio Inc., a Bayer subsidiary, seeks a Senior Director, Biostatistics to lead statistical strategy across non-clinical, CMC, and clinical programs. You will supervise statisticians, ensure rigorous study design, analysis, and reporting, and partner with cross-functional teams to advance gene therapy programs.

You will collaborate with regulatory authorities (FDA/EMA) and guide submissions while maintaining up-to-date knowledge of statistical methods and drug development guidelines.