Penfield Search Partners
Contact: Linda Aronova – email@example.com
- 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.
- 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