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Company

Original Job Post

Day One Biopharmaceuticals · 3 days ago

Associate Director, Biostatistics

United States

Full-time

Remote

Director

$185K/yr - $200K/yr

5+ years exp

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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. Work collaboratively with CRO vendors, Clinical Research, Drug Safety, Regulatory, Clinical Operation, and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting

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 (including review of work by programmers), as well as preparation of the clinical study report

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

Travel may be required (up to 15%)

Qualification

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Oncology drug developmentHealth authorities interactionRegulatory submissionsGCPsSAS programmingCDISC standardsSDTM data modelsADaM data modelsPharmaceutical development knowledgeData interpretationVendor managementProblem-solvingHard-workingCommunicationNegotiationTime-managementLeadershipFlexibilityCreativityAnalytical thinkingCollaboration

Required

PhD degree in Statistics/Biostatistics or equivalent with 5+ years 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