Day One Biopharmaceuticals is hiring a
Associate Director, Remote - United States
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Summary
The Associate Director of Biostatistics will work in collaboration with the Head of Biostatistics to provide statistical support for multiple projects, serve as the Statistical representative among cross-functional teams, manage statistical activities, and ensure regulatory compliance. The role requires a PhD degree in Statistics/Biostatistics or equivalent with 5+ years of experience in pharmaceutical/biotech industry, extensive hands-on experience in oncology drug development, excellent programming skills in SAS/R, and ability to work cross functionally.
Requirements
- PhD degree in Statistics/Biostatistics or equivalent with 5+ year of experience in pharmaceutical/biotech (Non-CRO) industry
- Extensive hands-on experience in oncology drug development including design and analysis of both early and late phase oncology trials
- Proven competencies in interaction with health authorities (such as FDA, EMA, PMDA) and eCTD (NDA/BLA) regulatory submissions
- Experience working in a quality regulated environment with a thorough understanding of GCPs
- Excellent programming skills in SAS/R
- Familiarity with industry data standards, including CDISC, SDTM and ADaM data models
- Ability and interest to work cross functionally as a strategic partner
- Self-motivated, flexible and creative leader, able to prioritize, multi-task and work in a fast-paced and demanding environment
- Effective communication skills: oral, written, with proven negotiation skills, and strong time-management
- A critical and logical thinker with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution
- Advanced knowledge of pharmaceutical development across all stages, with the ability to understand and interpret data/information and its practical application
- Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary
- Experience working with external vendors
- Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment
Responsibilities
- Serves as study statistician for clinical trials; develop trial design options and provide high quality decision support
- Evaluate and implement innovative designs and novel statistical methodologies as appropriate for clinical studies
- Act as the primary contact and provide oversight for all statistical related activities outsourced to CROs and external vendors
- Collaborate with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company
- Review data collection strategies and instruments, database design, edit check specifications, external data transfer specifications, and SDTM mapping as needed
- Prepare and/or review in detail the Statistical Analysis Plan (SAP) including development of standardized well-presented mock-up displays for Tables, Listings, and Figures (TLFs), conduct data analyses, and oversee preparation of all TLFs
- Create or review programming specifications for analysis datasets and TLFs, including SDTM and ADaM specifications
- Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, TLFs, study reports, manuscripts, and regulatory submission documents
- Oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical studies
- Conduct hands-on exploratory analyses, sample size computation, modeling and simulation, and create tools to gain meaningful insights from trial data as needed
- Interpret, summarize, and present data and statistical considerations to internal study team, senior management, advisory boarding meetings and global health authorities
- Keep abreast of new developments and advancements in statistics, drug development, science, and regulatory guidance
Benefits
- The salary range for this position is $185,000 - $200,000
- Please visit https://www.dayonebio.com/benefits to see our competitive benefits
This job is filled or no longer available
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