System One - Tarrytown, NY

posted 15 days ago

Full-time - Entry Level
Remote - Tarrytown, NY
Administrative and Support Services

About the position

The Biostatistician - Internal Medicine position is an entry-level contract role within a global pharmaceutical company, focusing on the statistical aspects of clinical studies. The role involves supporting clinical study teams, preparing study protocols, and performing statistical analyses under the guidance of senior staff. The position is ideal for candidates with a Master's or PhD in Statistics/Biostatistics and some experience in clinical research, particularly in Internal Medicine.

Responsibilities

  • Provide support to a clinical study team on all relevant statistical matters under direct supervision.
  • Ensure the clinical study is conducted in a manner that supports planned statistical analysis.
  • Participate in the preparation of study protocol and amendments under supervision.
  • Perform relevant sample size calculations and write the statistical methodology section of the protocol.
  • Review case report forms (CRF) and provide comments and feedback.
  • Develop statistical analysis plans (SAP).
  • Provide programming team with definitions and documentation for derived variables needed to produce planned Tables, Figures, and Listings (TFLs).
  • Perform statistical analysis according to the SAP, validate analysis programs, and review TFLs.
  • Prepare statistical methods and results sections for the clinical study report (CSR).
  • Provide statistical insight into interpretation and discussion of study results and work with the study team to move the CSR through the review/approval process.
  • Support/participate in project-related activities including preparation of BLA submissions and oversee CRO deliverables for contracted studies.

Requirements

  • Master's Degree in Statistics/Biostatistics or a related field required.
  • 2+ years of relevant experience in clinical research.

Benefits

  • Health and welfare benefits coverage options including medical, dental, and vision insurance.
  • Spending accounts.
  • Life insurance and voluntary plans.
  • Participation in a 401(k) plan.
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