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Company

BioSpace · 12 hours ago

Senior Director of Biostatistics

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$275K/yr - $340K/yr

8+ years exp

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Responsibilities

Lead the statistical strategy and technical activities for the development of an important program at Formation Bio. Drive all statistical activities related to study design, study delivery, data interpretation, and regulatory submissions for the program.

Develop study designs that will advance a molecule’s clinical development plan, lead to regulatory approval, and support patient access.

Drive the quantitative evaluation of study design options, clinical development options, and go/no-go criteria through simulation studies.

Collaborate with cross-functional teams on the development of regulatory documents and attend regulatory meetings.

Lead all aspects of statistical reporting for the program and ensure compliance with data submission guidelines, including review and/or authoring of protocols, statistical analysis plans, topline study results, clinical study reports, and publications.

Oversee CRO/Vendor activities to ensure GCP compliance, ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices.

Collaborate with Biometrics leadership and the technology team, supporting the development and implementation of tools for clinical trial design and simulation.

Qualification

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StatisticsBiostatisticsClinical trialsRegulatory experienceStatistical softwareR programmingSimulation studiesSASFACTSICH guidelinesProtocol developmentSAP developmentSDTM/ADaMTFL developmentClinical study reportingFDA interactionEMA interaction

Required

M.S. or Ph.D. in Statistics or Biostatistics

Experience in the pharmaceutical and/or biotechnology industry

At least 8 years’ relevant experience in the pharmaceutical and/or biotechnology industry for candidates holding an M.S. or 6 years’ relevant experience for candidates holding a Ph.D.

Deep understanding of the statistical designs and methods for early and/or late phase development programs.

A passion for quantitative decision making with experience evaluating clinical trial designs and clinical development decision criteria via simulation.

Expertise in either frequentist or Bayesian approaches to study design and decision making.

Ability to effectively communicate the results of complex statistical analyses and simulations to cross functional colleagues.

Solid understanding of ICH guidelines and their implications for study design and data analysis.

Extensive experience leading the statistical execution of multiple clinical trials as either a program lead or indication lead.

Detailed understanding of protocol development, SAP development, SDTM/ADaM and TFL development, and clinical study reporting is required.

Deep understanding of biostatistics regulatory requirements and guidelines.

Significant prior experience interacting with health authority agencies such as FDA and EMA.

Prior experience contributing to an NDA/BLA is required.

Experience utilizing statistical software for design and analysis of clinical trials (e.g., SAS, R, EAST, FACTS)

Proficient R programming skills are required.