Senior Director, Biostatistics & Clinical Development

Asklepios Biopharmaceutical Inc; Durham (NC); Hybrid; USD 180,000 - 250,000; Full time

Job summary

AskBio Inc. is seeking a Senior Director of Biostatistics to lead statistical strategy and oversight for global clinical programs. The role partners with cross-functional teams, regulators, and CROs to drive robust study designs and regulatory submissions.

The position is US-hybrid (RTP, NC / Philadelphia, PA / potentially other sites) and reports to the Head of Biometrics, Clinical Operations. Strong leadership and communication are essential.

Qualifications

• Ph.D. or M.S. in Statistics or a related field required.
• 10+ years of pharmaceutical R&D experience in biotech/pharma.
• Strong knowledge of design of experiments, trial design concepts, and regulatory science.
• Experience preparing and submitting NDAs/INDs/BLA filings with regulators.
• Experience in CRO management, contracting, and vendor oversight.
• Excellent communication and leadership skills.

Responsibilities

• Provide technical leadership for statistical strategy and trial design across programs.
• Oversee statistical content for trials and study reports; interact with FDA/EMA.
• Guide statisticians, programmers, and data managers; ensure high-quality deliverables.
• Collaborate on protocols, SAPs, CSR content, and regulatory submissions.
• Represent Biostatistics in cross-functional teams and external discussions.

Skills

Statistics

Drug development

Leadership

Communication

SAS/R

Education

PhD or MS in Statistics or related field

Tools

SAS

R

Job description

AskBio Inc. is seeking a Senior Director of Biostatistics to lead statistical strategy and oversight for global clinical programs. The role partners with cross-functional teams, regulators, and CROs to drive robust study designs and regulatory submissions.

The position is US-hybrid (RTP, NC / Philadelphia, PA / potentially other sites) and reports to the Head of Biometrics, Clinical Operations. Strong leadership and communication are essential.