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

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
Applies knowledge of regulatory requirements regarding statistical principles to ensure the company meets its regulatory, scientific, and business objectives
Collaborates 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

Preferred Qualifications

Preference for being located in the San Francisco Bay or Boston, however, has the potential to be fully remote

Benefits

The salary range for this position is $185,000 - $200,000
Please visit https://www.dayonebio.com/benefits to see our competitive benefits

Day One Biopharmaceuticals is hiring a Associate Director