Executive Director Biostatistics

1 week ago

san francisco, United States Meet Full time

Executive Director, Biostatistics - Head of Biostatistics


(Hybrid 3 days weekly in South San Francisco, CA)


Position Overview

The Executive Director of Biostatistics will provide strategic leadership, oversight, and execution of the biostatistics function to support a growing portfolio of clinical development programs. This role offers strategic statistical input for drug development planning, including feasibility assessments, study design, statistical methodologies, data interpretation, and regulatory submissions (IND, NDA, MAA, etc.). The Director will collaborate with Biometrics, Data Management, Statistical Programming, and Data Science to build a top-tier biometrics function. They will oversee biostatistics deliverables through external vendors or internal resources and ensure high-quality, timely, and accurate outputs that meet regulatory requirements.

Reporting to the VP of Biometrics, this leader will provide strategic and technical direction for the biostatistics function, fostering excellence in delivery.


Key Responsibilities

  • Provide strategic leadership for the biostatistics function, aligning with senior leadership and program objectives.
  • Build and manage a high-performing biostatistics team while fostering a culture of collaboration, innovation, and excellence.
  • Offer strategic input on product development, including statistical study design, clinical endpoint selection, sample size justification, statistical analysis methodologies, and data interpretation.
  • Review and contribute to clinical data-related documents such as protocols, data management plans, CRFs, CSRs, etc.
  • Act as the primary point of contact for outsourced biostatistics activities, ensuring the quality and timely completion of clinical data deliverables.
  • Lead the development and optimization of biometric processes, focusing on efficiency and quality while adhering to industry best practices.
  • Implement innovative study designs and novel statistical methodologies across various therapeutic areas.
  • Collaborate closely with cross-functional teams (Medical, Data Management, Statistical Programming, Safety, Clinical Operations, and Regulatory) to:
  • Review protocols, generate statistical methods sections, and oversee clinical trial design to ensure robust, cost-effective, and statistically sound trials.
  • Generate or review randomization schedules and ensure accurate application by IVRS/IWRS.
  • Review data collection strategies, database design, and SDTM mapping as needed.
  • Prepare and review detailed Statistical Analysis Plans (SAPs), mock-ups for Tables, Listings, and Figures (TLFs), and oversee the production and review of TLFs.
  • Create or review programming specifications for analysis datasets and TLFs, ensuring accurate and compliant deliverables.
  • Lead study unblinding and TLF validation post-database lock.
  • Manage external and internal biostatistics and statistical programming resources supporting clinical studies.
  • Develop and implement standard operating procedures, work instructions, and guidelines for the biostatistics team.
  • Ensure accurate, statistically valid deliverables across protocols, SAPs, TLFs, reports, manuscripts, and regulatory submissions.
  • Oversee submission of clinical data to regulatory agencies, ensuring compliance with project needs and standards.
  • Provide statistical leadership in preparing marketing applications for regulatory agencies.
  • Stay updated on advancements in science, medicine, technology, and statistical standards relevant to drug development.
  • Perform additional duties as required.


Qualifications

  • PhD in Statistics/Biostatistics with at least 15 years of clinical development, analysis, and reporting experience in the biotech/pharmaceutical industry.
  • Proven experience in interactions with regulatory authorities (FDA, EMA, etc.) and expertise in eCTD submissions (NDA/BLA).
  • Experience overseeing external vendors for biostatistical deliverables.
  • Comprehensive knowledge of CDISC submission requirements (SDTM, ADaM, Define.xml, etc.).
  • Proven ability to optimize biometrics processes with a focus on efficiency and quality.
  • Strong knowledge of statistical methodologies for clinical trial design and analysis.
  • Experience implementing innovative study designs and statistical methodologies.
  • Strong understanding of clinical development and regulatory requirements across multiple regions.
  • Proficiency in SAS or R programming is highly desirable.
  • Strong communication and collaboration skills, especially in a small biotech setting.
  • Ability to travel occasionally for business needs.

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