• Direct Hire
  • Remote

SimulStat

*Onsite San Diego, CA highly preferred )once everyone returns to the office TBD), however will still consider remote candidates. If remote, candidate will need to be open to traveling to San Diego a maximum of once a month for a full work week (client covers all travel costs)

The Associate Director, Biostatistics (HEOR, Market Access, RWE) will work closely with the Vice President, Biometrics in providing statistical support to Health Economics and Outcomes Research, Market Access, and Real World Evidence activities in support of drug development and commercialization. This role oversees statistical aspects of assigned studies or projects to ensure that scientific, regulatory, and quality requirements are met and that plans are aligned with development and commercialization goals. The incumbent will provide statistical knowledge in study design, statistical analysis, reporting, and interpretation of data. This role will provide hands-on support to project teams by conducting statistical analysis, overseeing external vendors, and working closely with programming and data management to plan, organize, coordinate, review, and ensure timeliness and quality of Biometrics deliverables for assigned studies/projects. The incumbent will collaborate with cross-functional teams composed of internal and/or external experts and could also serve as the Biometrics team lead for a project.

Essential Functions:

  • Represent the statistics function and provide statistical leadership in support of clinical studies or projects, depending on the level of experience.
  • Collaborate with cross-functional team in support of HEOR, Market Access, and RWE activities.
  • Lead the planning and execution of analysis of claims databases, electronic medical records, disease registries, or other epidemiological data sources in coordination with the Market Access, HEOR, and Biometrics teams
  • Work directly with study/project teams to identify statistical issues, and to propose and implement solutions.
  • Provide statistical input to reports, value/reimbursement dossiers, publications, and other internal or external data requests. Perform statistical modeling and analyses as needed.
  • Prepare, review and/or approve analysis, case report forms, DB specifications, validation plans, TFLs, reporting and analysis datasets specifications, and supporting documentation for observational studies or clinical trials.
  • Review and provide feedback on analytical work conducted by colleagues, external collaborators, or third-party service providers related to HEOR, Market Access, and RWE
  • Provide statistical oversight to internal and/or external Biometrics teams to ensure timeliness and quality of study/project deliverables.
  • Contribute to the development and maintenance of Biometrics-related SOPs, work practice documents, technical standards, and specification documents.
  • Research and apply new statistical approaches as needed. Develop new or leverage existing statistical methodologies to convert data into information to enable decision making.

Qualifications:

  • Master’s Degree in Statistics/Biostatistics, Epidemiology, Health Economics is required, Ph.D. is preferred.
  • Minimum 6-8 years (+MS) or 4-6 years (+PhD) of relevant experience in the biopharmaceutical industry.
  • At least 3 years of experience in HEOR, Market Access, or RWE. Experience working with value/reimbursement dossiers is a plus. Experience in orphan or rare diseases is a plus.
  • Hands on experience in extracting, organizing, and analyzing data from claims databases, electronic medical records, registries, or other epidemiological data sources.
  • Proficiency in vendor oversight experience.
  • Understanding of fundamental principles, best practices, and industry standards applicable to the HEOR, Market Access, or RWE.
  • Extensive experience with study designs, power/sample size computations, (longitudinal) data analysis, survival analysis, Bayesian analysis, statistical modelling, and simulations.
  • Extensive experience in with SAS and R. Experience with other statistical or database software is a plus.
  • Ability to manage multiple, complex tasks with competing timelines.
  • Excellent communication and collaboration skills. Ability to explain statistical concepts to non-statisticians.
  • Solution oriented, attention to detail, interest, and ability to perform in a high-demand and dynamic working environment.
  • Able to travel (up to 20%) domestically and internationally.
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