Biostatistics Associate Director

A company is looking for an Associate Director, Biostatistics.

Key Responsibilities

Serve as a project statistician ensuring scientifically sound study designs and regulatory compliance

Participate in protocol development and prepare statistical sections for clinical study reports

Provide statistical support for clinical development programs and regulatory submissions

Required Qualifications

MS or PhD in statistics, biostatistics, or related fields with high statistical content; PhD preferred

A minimum of 6 years of relevant experience in the pharmaceutical or biotechnology industry (9 years if MS)

Knowledge of ICH / EMA / FDA guidelines and experience in regulatory interactions and submissions

Programming skills in SAS (required) and R (preferred)

Experience in implementation of CDISC, SDTM, and ADaM datasets