Job Description:

We are seeking an experienced Senior Biostatistician to lead statistical analysis planning and collaboration efforts for global clinical studies. The ideal candidate will have strong experience in drafting SAPs, reviewing ADaM specifications and TLFs, and effectively communicating with sponsors.

Key Responsibilities:

• Independently draft Statistical Analysis Plans (SAP) and TLF shells in accordance with study protocols and regulatory standards.
• Review ADaM specifications and ensure alignment with the SAP and study design.
• Perform quality reviews of Tables, Listings, and Figures (TLFs) to ensure accuracy and consistency.
• Communicate proactively and clearly with sponsor stakeholders, providing expert statistical insight.
• Ensure high-quality documentation and audit readiness of statistical deliverables.
• Collaborate with programming and data management teams to support study timelines.

Required Skills and Experience:

• 8–10 years of experience as a biostatistician in the pharmaceutical or CRO industry.
• Proven ability to draft SAPs and TLF shells independently.
• Strong communication skills with demonstrated experience in direct sponsor interaction.
• Must be available for US daytime hours to accommodate sponsor meetings and coordination.
• Strong attention to detail and ability to perform in-depth reviews of TLFs.
• Ability to review and validate ADaM specifications in accordance with CDISC standards.