Biotech/Pharmaceutical

Biostatistician

Contract

Penfield Search Partners

Contact: Linda Aronova – laronova@penfieldsearch.com

Job Responsibilities:

  • Provides statistical input to clinical development plans (CDP), including study design, sample size, primary and secondary endpoints, and statistical analysis method by working together with clinical pharmacological and other functions.
  • Support protocol development on early phase studies to make sure clear description of clinical study design, randomization, statistical analysis methodology and key statistical activities in protocol.
  • Develops a detailed Statistical Analysis Plan (SAP) to document technical considerations and corresponding mock tables, figures and listings.
  • Support final tables, figures and listings development for final study report (CSR), publication and regulatory submissions.
  • Reviews final statistical tables, listings, and figures.
  • Provides specs to SAS programmers for generating analysis datasets.
  • Produce Randomization codes.
  • Coordinate with data management to Review CRF and IDRP, review and approve database structure and edit-check specifications.
  • Proactive and timely communication with study team on stats activities and its progress per planned timeline by working with Clinical management.

Required Qualifications/Experience:

  • Master’s or PhD in Statistics or Biostatistics with a minimum of 3 years of experience in the pharmaceutical industry
  • In-depth knowledge of statistical principles, applications, and SAS programming software
  • Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
  • Awareness of new drug developments and statistical methodologies in the business
  • Working knowledge of applicable U.S. regulatory requirements and NDA preparation for submissions

Tagged as: Biostatistician