Head of Biometrics
LOCATION: South San Francisco
REPORTS TO: Product Development
Primary Objective of Position:
The Head of Biometrics will oversee biostatistics, clinical data management and programming for all Day One Biopharmaceuticals assets, starting with defining the data foundation of DAY101, Day One’s lead asset. The individual will be a key member of Day One’s cross functional teams, expected to be a forward looking expert in the fields of biostatistics, data management and programming, able to apply their expertise and experience to the most immediate project needs, as well as the overall Day One pipeline strategy and anything in between, including directing vendors and eventually assembling a world-class team.
- Strategically partner with Clinical Development, Regulatory, and Clinical Operations and other relevant expertise areas to provide drug development leadership on the design and execution of robust clinical development plans for novel therapeutics.
- Leverage advances in the field and, where appropriate, employ innovative trial designs & statistical methodologies in the design of efficient and effective clinical trials.
- Work in collaboration with internal and external partners in the study design, support endpoint selection and sample size calculations, analysis, interpretation, and publication of clinical trial data
- Execute protocols, statistical analysis plans, study reports, ensure statistical integrity of presentations and publications of clinical studies by applying past experiences and provide oversight to data management processes and team
- Effectively communicate and discuss complex statistical & drug development issues with Day One ExecutiveTeam, and other stakeholders and influence the pipeline strategy
- Manage external vendors and serve as a key biostats/data management strategic direction and liaison with external organizations for the studies where relevant
- Ensure data transfer specifications are in place and review data transfers for consistency with company data standards and SDTM specifications
- Identify and lead efforts to improve data infrastructure and processes to support needs of the product team, and any relevant development functions
- Ensure scientific rigor & timely availability of all data management, programming and biostatistical deliverables
- Actively manage resources and staffing to ensure a nimble and motivated team and efficient and high quality deliverables
- Develop and retain top talent to form an unmatched statistics, statistical programming, and data management team
Skills & Abilities:
- Effective at attracting and developing talent to build a highly effective technical function
- Capable and motivated to improve both strategic and operational excellence
- Seasoned decision-maker who can lead the team in soliciting and analyzing multiple and potentially conflicting points of view
- Possesses effective communication skills. Active listener and fosters a team climate of open and honest communication.
- Motivates others by creating a climate in which team members strive to do their best. Invites input from others and shares ownership for team success.
- Fosters trust through strong partnership and collaboration with all team/sub-team members and leaders/stakeholders.
- Excellent interpersonal skills with particular emphasis on communication, influencing, & relationship building.
- Experience managing teams of Statisticians, Data Managers, and SAS Programmers
- Experience interacting with U.S. and Global regulatory authorities, including NDA/BLA/MAA filings
Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment.
- 7+ years of experience in academia or industry. Pharmaceutical/biotech/CRO industry experience preferred
- PhD in Biostatistics and or related field
- Strong knowledge of theoretical and applied statistics and clinical trial data management
- Hands-on ability to drive and lead strategies for clinical trials of drug candidates from first-in-human testing to all later phases of clinical investigation, including pivotal Phase 2/3 studies and NDA/BLA submissions
- Demonstrated success leading the statistical strategy, analysis, and design of clinical development programs across therapeutic areas and oversight of data management and programming teams
- Experience interacting with CROs in the management of Biometrics deliverables including databases set up, intiation, conduct, and closure of studies towards data generation and filing
- Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA
- Experience programming in SAS or R and other relevant statistical software solutions
- Strong application of innovative study designs and developing milestone criteria (e.g. Go/No Go criteria, adaptive designs, virtual control arms etc)
- Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and data modeling is strongly preferred
- Experience is SAS programming is required; proficiency in SAS Base, SAS/STAT, SAS Graph, and SAS Macro Language is a plus
- Experience with Tableau, R, Python or other languages is a plus
- Computer proficiency in Microsoft Office, including: Word, Excel, PowerPoint, Project, and Documentum technology.
- Demonstrated experience in project management and a clear understanding of US and ex-US requirements with regard to submission content and format. The ability to multitask and manage multiple and changing priorities. A proven ability to work under pressure and adhere to deadlines