Executive Director, Head of Biostatistics Job Listing at Kelly Services in South San Francisco, CA (Job ID 10088821)

Description

Executive Director/Senior Director, Head of Biostatistics  

• Direct Hire: Full time, direct employee of our client
• Location: South San Francisco, CA (hybrid with expecting 2-3 days onsite a week)
  • Relocation option potential for the right experience
• Salary: $260-350k. Salary is based on level of experience and total package includes bonus potential and equity options. 

Kelly Science and Clinical is hiring a Senior Director or Executive Director level, Head of Biostatistics, for our biotech client who focuses on innovative pipelines of transformative treatment options that have the potential to change lives.

Position Summary
 
The Head of Biostatistics will report directly to the EVP, Chief Development Officer, and will be responsible for leading the biostatistics efforts for all clinical development programs. This role will provide strong scientific and technical operational oversight across all clinical trials to ensure rigorous statistical methodology, data integrity, and regulatory compliance. The ideal candidate should be a collaborative leader, with a proven track record of guiding cross-functional teams through early and late-stage clinical trial designs, data analyses and be familiar with global regulatory requirements for statistical data submissions. The level of the role will depend on experience. The candidate will oversee and manage external vendors and consultants responsible for day-to-day statistical programming and analysis.  The candidate must have a proven track record of contributing to regulatory submissions such as INDs, NDAs or MAAs. 

Essential Functions / 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

Required Education and Experience:

• 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 Education and Experience:

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

Additional Eligibility Qualifications/Competencies

• Ability to adapt quickly, succeed in a team environment and learn new tasks independently.
• Excellent interpersonal and communications skills, ability to build productive internal/external working relationships with cross-functional teams.
• The successful candidate must be flexible and adaptable to the needs of a small company.

 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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