Sr. Group Head, Biometrics and Biostatistics

Who We Are

23andMe, the leading consumer genetics and research company, has accumulated a wealth of genotypic and phenotypic information from participants committed to improving human health through advances in genomics. Our Therapeutics team in South San Francisco leverages this data to discover and develop new treatments that can offer significant benefits for patients with serious, unmet medical needs.

This dedicated research and drug development group identifies novel targets using 23andMe's genetic database and performs preclinical research to advance programs towards clinical development. We currently have programs across several therapeutic areas, including but not limited to oncology, respiratory, and cardiovascular diseases. More information about our Therapeutics team is available at https://therapeutics.23andme.com/.

The Senior Group Head, Biometrics and Biostatistics will be responsible for building a biometrics organization to support 23andMe’s therapeutics programs from pre-IND stage through all phases of clinical development for 23andMe owned and led programs, and will provide biostatistics input for earlier stage programs and partnered programs. This person will provide leadership and management skills to enable 23andMe Therapeutic programs to successfully progress through preclinical and clinical development stages to enable successful marketing authorizations and commercialization by 23andMe or collaborative partners, including the ability to hire and develop talent, to develop high functioning teams, and will have demonstrated a track record for successful delivery of clinical trial data leading to regulatory approvals and demonstrated collaborativeness with academic, industry, advocacy and regulatory thought leaders. This person will assess Therapeutics biometrics infrastructure and will work with internal support and external vendors to create a fit-for-purpose environment to assess clinical trial data to support regulatory and publication analysis needs.  The successful individual will join a dynamic, enthusiastic, innovative and collaborative team who are discovering new opportunities for therapeutic intervention and advancing impactful medicines toward regulatory approval. The successful individual will be passionate about his or her focus on patients and will inspire others.

What You’ll Do

• Directs the design, development, modification and evaluation of a technical infrastructure to expedite the operation and evaluation of clinical trials 
• Defines the statistical strategy and ensures appropriate statistical methodologies applied to study designs and data analyses for clinical trials.
• Collaborates with clinical, operational, and regulatory team members and project leaders to drive quantitative decision making for Development programs
• Represents and/or oversees the biostatistics function in interactions with regulatory health authorities
• Evaluates clinical development infrastructure and resourcing  and proposes and implements stage-appropriate infrastructure for clinical data management and clinical data analysis
• Directs a fit-for-purpose organization to inform and execute clinical development plans from clinical trial initiation through global regulatory approvals, including the hiring and/or contracting of biostatistics, data management, and statistical programming personnel
• Relates science/mechanisms of action to the target clinical product profile in diverse therapeutic areas and partners with clinical leadership to propose clinical evaluation strategies including clinical development planning
• Provides leadership for the statistically robust utilization of human genetic information and other systemic biomarker information to improve probability of success for clinical drug development programs
• Provides leadership to and support the success of new and existing collaborations/alliances with academic institutions and pharma/biotech companies
• Works with senior leadership to help represent the company as a senior spokesperson at appropriate scientific, medical, regulatory, business and other professional meetings
• Coaches, mentors and manages employees, with varying levels of experience, for performance and scientific growth
• Maintain compliance with all company policies and procedures
• Perform other related duties as assigned

What You’ll Bring

• PhD in a biostatistics field or equivalent industry experience
• Substantial drug development industry experience including leading data analysis teams for pivotal phase 3 clinical trials, and NDA/BLA filings
• Understanding of clinical evidence base guiding the use of molecular and other markers in patient selection
• Working knowledge o