Summary:

Our client, a global pharmaceutical organization, has engaged GForce Life Sciences to provide them with an experienced Biostatistician to drive projects and process improvement activities across the organization.

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.

Requirement:

• Masters or PhD in Statistics or Biostatistics 
• Minimum of 3 years of experience in the pharmaceutical industry.
• In-depth knowledge of statistical principles, applications, and SAS programming software.
• Awareness of new drug developments and statistical methodologies in the business.
• Working knowledge of applicable U.S. regulatory requirements and NDA preparation for submissions.

Additional Notes

• 12 month contract
• Remote - EST timezone.
• Healthcare Benefits Available
• Start ASAP