Executive Director, Biometrics & Data Strategy

EPM Scientific; San Francisco (CA); Hybride; USD 280 000 - 380 000; Plein temps

Résumé du poste

EPM Scientific is partnering with a clinical-stage oncology biotechnology company to recruit an Executive Director, Head of Biometrics in the San Francisco Bay Area. The role leads Biostatistics and Statistical Programming, shaping biometrics strategy and regulatory interactions to enable data-driven decisions across programs.

Reporting to the CMO, this leader will build and guide a high-performing biometrics team, oversee external CROs, and drive submissions for NDA/BLA filings in a fast-paced,

Qualifications

• PhD in Biostatistics or related quantitative field.
• 15+ years in biostatistics/statistical programming in biotech/pharma.
• Experience as senior biometrics leader in biotech.
• Oncology clinical development expertise.
• Experience with NDA/BLA submissions and regulatory interactions.

Responsabilités

• Provide strategic leadership of Biostatistics and Statistical Programming.
• Lead biometrics strategy across development programs from early-stage to registrational trials.
• Oversee study design, endpoint selection, SAPs, and analysis planning.
• Represent statistical activities in FDA/EMA interactions and regulatory submissions.
• Oversee SDTM/ADaM and submission-ready datasets; manage CROs and vendors.
• Partner with Clinical Development, Regulatory Affairs, Medical Affairs, and external vendors.
• Present data-driven recommendations to executive leadership and stakeholders.
• Establish biometrics processes, standards, and governance frameworks.
• Build, mentor, and develop a high-performing biometrics team while managing CRO and vendor relationships.

Connaissances

Strategic biometrics leadership

Cross-functional collaboration

Executive-level communication

Vendor management

Formation

PhD in Biostatistics/Statistics/Mathematics

Outils

CDISC Standards

GCP/ICH knowledge

Regulatory submission experience

Description du poste

EPM Scientific is partnering with a clinical-stage oncology biotechnology company to recruit an Executive Director, Head of Biometrics in the San Francisco Bay Area. The role leads Biostatistics and Statistical Programming, shaping biometrics strategy and regulatory interactions to enable data-driven decisions across programs.

Reporting to the CMO, this leader will build and guide a high-performing biometrics team, oversee external CROs, and drive submissions for NDA/BLA filings in a fast-paced,