Head of Biometrics

EPM Scientific; San Francisco (CA); Híbrido; USD 280.000 - 380.000; Jornada completa

Descripción de la vacante

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,

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Strategic biometrics leadership

Cross-functional collaboration

Executive-level communication

Vendor management

Educación

PhD in Biostatistics/Statistics/Mathematics

Herramientas

CDISC Standards

GCP/ICH knowledge

Regulatory submission experience

Descripción del empleo

We are partnering with an innovative clinical-stage oncology biotechnology company developing novel therapies for patients with significant unmet medical needs.

The company is seeking an Executive Director, Head of Biometrics to provide strategic leadership across Biostatistics and Statistical Programming. Reporting into CMO and serving as a key member of the development leadership team, this individual will be responsible for shaping biometrics strategy, supporting regulatory interactions, and driving data-driven decision-making across the portfolio.

This is a unique opportunity to join a growing oncology biotech and build upon a biometrics function that will play a critical role in future clinical and regulatory milestones.

Key Responsibilities

• Serve as the company's biometrics leader, providing strategic oversight of all Biostatistics and Statistical Programming activities
• Lead biometrics strategy across clinical development programs from early-stage studies through registration-enabling trials
• Provide statistical leadership for study design, endpoint selection, protocol development, sample size determination, and analysis planning
• Oversee the development and review of Statistical Analysis Plans (SAPs)
• Act as the primary statistical representative for FDA, EMA, and other global health authority interactions
• Lead biometrics contributions supporting regulatory submissions, including NDA/BLA filings
• Oversee statistical programming deliverables, including SDTM, ADaM, TLFs, and submission-ready datasets
• Partner closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, and external vendors
• Present data-driven recommendations to executive leadership and key stakeholders
• Establish biometrics processes, standards, and governance frameworks that support organizational growth
• Build, mentor, and develop a high-performing biometrics team while managing CRO and vendor relationships

Qualifications

• PhD in Biostatistics, Statistics, Mathematics, or a related quantitative discipline
• 15+ years of experience in biostatistics and/or statistical programming within biotechnology or pharmaceutical development
• Previous experience serving as a senior biometrics leader within a biotech environment
• Deep expertise in oncology clinical development
• Experience supporting NDA and/or BLA submissions and regulatory agency interactions
• Strong knowledge of CDISC standards, GCP, ICH guidelines, and global regulatory requirements
• Proven ability to influence cross-functional strategy and executive-level decision making
• Experience overseeing external CROs and biometrics vendors within a lean, fast-paced environment

Location: San Francisco Bay Area, CA (Hybrid)