Associate Director, Biostatistics - Lead Phase 3 Trials

Cytel; Illinois; In loco; USD 140.000 - 210.000; Tempo pieno

Descrizione del lavoro

Cytel, a leader in biostatistics, seeks an Associate Director of Biostatistics dedicated to a major pharma client, embedding with the client team to support or lead trials and advance drug development with advanced statistical methods.

You will provide statistical development support, collaborate with cross-functional partners, and apply SAS and R for analyses, with ownership of study-level outputs and regulatory submissions.

Competenze

• Master’s degree in Statistics or related quantitative discipline; PhD preferred.
• 7+ years of experience supporting clinical trials in pharma/biotech.
• Strong knowledge of adaptive design and group sequential methods.
• Proficient in SAS and/or R for statistical analysis and QC.

Mansioni

• Lead statistical activities for assigned clinical trials (Phases 3) from design to reporting.
• Represent Statistics on cross-functional trial teams and collaborate with stakeholders.
• Oversee internal programming and CRO contributions on trials.
• Lead database lock, submissions, safety reporting, and regulatory inquiries.
• Collaborate with clinical, data management and programming to finalize study outputs.
• Coordinate statistical activities across studies within the project.

Conoscenze

Adaptive design

Group sequential

Count data methods

Cross-functional collaboration

Regulatory knowledge

Communication

Project management

Independent ownership

Formazione

Master’s degree in Statistics or related quantitative discipline

PhD preferred

Strumenti

SAS

R

Descrizione del lavoro

Cytel, a leader in biostatistics, seeks an Associate Director of Biostatistics dedicated to a major pharma client, embedding with the client team to support or lead trials and advance drug development with advanced statistical methods.

You will provide statistical development support, collaborate with cross-functional partners, and apply SAS and R for analyses, with ownership of study-level outputs and regulatory submissions.