Senior Director, Biostatistics & Clinical Strategy

AskBio Inc.; United States; Ibrido; USD 180.000 - 250.000; Tempo pieno

Descrizione del lavoro

AskBio Inc. in the United States is seeking a Senior Director of Biostatistics to provide technical leadership across non-clinical, CMC, and clinical development programs and oversee statistical deliverables. The role involves mentoring statisticians, guiding trial designs, and supervising data analyses to support regulatory submissions.

The position is based in a US hybrid setting (RTP, NC; Philadelphia; Ohio) and reports to the Head of Biometrics.

Competenze

• Ph.D. or M.S. in Statistics or a related field.
• 10+ years of pharmaceutical R&D statistics experience.
• Strong knowledge of design of experiments and trial design concepts.
• Experience preparing NDA/BLA submissions and regulatory communications.

Mansioni

• Provide technical leadership for statistical deliverables across programs.
• Lead statistical strategy for key development programs and endpoints.
• Manage CROs, vendors, and internal statisticians to ensure high-quality analyses.
• Represent Biostatistics in FDA/EMA interactions and regulatory submissions.
• Develop and maintain QA processes for statistical deliverables and documentation.

Conoscenze

Leadership

Regulatory collaboration

Statistical expertise

Communication

Formazione

Ph.D. in Statistics

M.S. in Statistics

Strumenti

SAS

R

Descrizione del lavoro

AskBio Inc. in the United States is seeking a Senior Director of Biostatistics to provide technical leadership across non-clinical, CMC, and clinical development programs and oversee statistical deliverables. The role involves mentoring statisticians, guiding trial designs, and supervising data analyses to support regulatory submissions.

The position is based in a US hybrid setting (RTP, NC; Philadelphia; Ohio) and reports to the Head of Biometrics.