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Kelly Science, Engineering, Technology & Telecom · 1 day ago

Executive Director, Head of Biostatistics

South San Francisco, CA

Full-time

Hybrid

Director/Executive

$260K/yr - $350K/yr

10+ years exp

Kelly Science, Engineering, Technology & Telecom is hiring for the position of Executive Director, Head of Biostatistics for a biotech client focused on transformative treatment options. The role involves leading biostatistics efforts for clinical development programs, ensuring rigorous statistical methodology, data integrity, and regulatory compliance.

Staffing & Recruiting

Responsibilities

Provide statistical input across clinical development programs, including clinical trial study design, clinical protocol development, authoring and reviewing statistical analysis plans, and analysis planning

Provide expertise in designing complex clinical trials including trials with adaptive design and platform trials

Author and/or review protocols, electronic case report form (eCRF) designs to ensure data collection meets the requirements of statistical analyses, clinical study reports including statistical methods and interpretation of study results

Manage external CROs/consultants to ensure on-time, high-quality statistical support and deliverables

Lead the development and review of key documents, including statistical analysis plans, clinical study reports, and regulatory filings (e.g., NDA, MAA)

Represent biostatistics in interactions with regulatory agencies, including preparing responses and meeting participation

Ensure compliance with industry and regulatory standards, including ICH, GCP, FDA, EMA, and CDISC

Lead standardization and process improvement efforts for Biostatistics function, and contribute to cross-functional process improvement efforts including the definition of biostatics templates and standards

Qualification

PhD in BiostatisticsClinical Trial DesignStatistical Software SASStatistical Software RRegulatory Submissions INDsRegulatory Submissions NDAsManaging External TeamsStatistical Methods ExpertiseCross-Functional CollaborationLeadership SkillsProject Management SkillsInterpersonal Skills

Required

PhD degree in statistics, biostatistics, or related quantitative field

A minimum of 10+ years' experience in biostatistics supporting clinical trials in pharmaceutical, biotech or CRO

Proven track record of managing external clinical biostatistics team

Extensive experience designing complex late-stage clinical trials (e.g., basket, platform, umbrella or factorial designs)

Expert knowledge of statistical methods for clinical trials, regulatory guidelines, and CDISC standards (SDTM, ADaM)

Excellent proficiency in statistical software (e.g., SAS, R)

Experience with worldwide global regulatory interactions and submissions with hands-on experience contributing to INDs, NDAs, MAAs, or other regulatory submissions

Experience in cross-functional drug development strategies including clinical development planning, go/no-go decision-making, strategic and technical governance review, working with data safety monitoring boards, and late-stage study execution

Ability to develop fit-for-purpose innovative statistical solutions to meet development program needs. Deep early and late-stage development experience

Excellent written and oral communication, leadership, and project management skills

Experience managing budgets

Ability to be onsite (hybrid with 3 days onsite a week) and travel as needed around 5%

Must be authorized to work in the United States

Preferred

Familiarity with trial designs for antivirals and liver diseases such as MASH

Benefits

Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability

Retirement savings plan

Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)

Transit spending account

Paid sick leave under the applicable state or local plan