Day One Biopharmaceuticals is hiring a
Associate Director, Remote - United States

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