Senior Biostatistics Manager

A company is looking for a Senior Manager Biostatistics.

Key Responsibilities

Lead study-level tasks to ensure statistical integrity and contribute strategically to projects

Collaborate with biometrics and cross-functional teams to meet product deliverables and timelines

Conduct independent analyses and propose novel statistical methodologies to enhance study results

Required Qualifications

PhD in Statistics or Biostatistics with a minimum of 3 years of post-graduate experience in clinical trials; 6 years for Master's degree

Experience with NDA / BLA / MAA activities and regulatory interactions preferred

Proficient in study-level work, including authoring SAP and TFL specifications

Familiarity with ICH guidelines and FDA / EMA regulatory guidance

Knowledge of SAS and R; familiarity with CDISC standards such as SDTM and ADaM is preferred