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 of genetic/genomic and bioinformatics technologies and their application to translational approaches
Ability to collaborate effectively and respectfully with internal and external multi-disciplinary research and development teams
Outstanding organizational leader and mentor, with a track record of organization/team-building, talent attraction, and retention
Exceptional written and verbal communication capabilities

About Us

23andMe, headquartered in Sunnyvale, CA, is a leading consumer genetics and research company. Founded in 2006, the company’s mission is to help people access, understand, and benefit from the human genome. 23andMe has pioneered direct access to genetic information as the only company with multiple FDA authorizations for genetic health risk reports. The company has created the world’s largest crowdsourced platform for genetic research, with 80 percent of its customers electing to participate. The platform also powers the 23andMe Therapeutics group, currently pursuing drug discovery programs rooted in human genetics across a spectrum of disease areas, including oncology, respiratory, and cardiovascular diseases, in addition to other therapeutic areas. More information is available at www.23andMe.com.

At 23andMe, we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at accommodations-ext@23andme.com. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.

Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.

Pay Transparency
23andMe takes a market-based approach to pay, and amounts will vary depending on your geographic location. The salary range reflected here is for a candidate based in the San Francisco Bay Area. The successful candidate’s starting pay will be determined based on job-related skills, experience, qualifications, work location, and market conditions. These ranges may be modified in the future.

San Francisco Bay Area Base Pay Range

$266,000—$398,000 USD

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Sr. Group Head, Biometrics and Biostatistics

Therapeutics - Therapeutics Development

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