Biostatistics

Job Overview:

In this role, you will support a clinical study team by contributing to the design, execution, and interpretation of statistical analysis under the guidance of senior staff. You will collaborate closely with the study team to ensure that clinical studies are conducted in a manner that aligns with planned statistical analysis and regulatory requirements.

Key Responsibilities:

• Collaborate with Senior Staff: Work under the direct supervision of senior team members to provide statistical expertise for clinical studies, ensuring adherence to planned analysis.
• Study Protocol Preparation: Assist in drafting and revising study protocols and amendments, including conducting sample size calculations and writing the statistical methodology sections.
• Case Report Form (CRF) Review: Provide insightful feedback and comments on CRFs to ensure data collection is optimized for statistical analysis.
• Statistical Analysis Plan (SAP) Development: Lead the development of SAPs and communicate programming requirements for derived variables used in Tables, Figures, and Listings (TFLs).
• Data and Programming Specifications: Collaborate with the programming team to establish data and programming specifications needed for study analysis.
• Statistical Analysis Execution: Perform and validate statistical analyses according to the SAP, reviewing TFLs and preparing statistical sections for the Clinical Study Report (CSR).
• Cross-functional Collaboration: Provide statistical interpretation of study results and collaborate with the study team to finalize and approve CSRs.
• Regulatory and Submission Support: Contribute to regulatory submissions, such as BLAs, and oversee deliverables from CROs for outsourced studies.

Required Qualifications:

• Master's Degree in a relevant field (e.g., Statistics, Biostatistics).
• 2+ years of relevant experience in statistical support for clinical studies.