Director of Biostatistics

Key Responsibilities And Duties

• Leads and oversee biostatistical strategy for one or more clinical development programs.
• Serves as a key contributor to study design and protocol development.
• Develops statistical analysis plans (SAPs) and table, listing, and figure (TLFs) shells.
• Ensures that clinical trial designs and proposed analysis methods are robust and follow regulatory guidelines (FDA, EMA, etc.).
• Oversees the production of TLFs for interim and final analyses and ensures that it is of high quality and delivered on time.
• Manages statistical vendors for independent data monitoring committees.
• May supervise junior biostatisticians.

Education, Qualifications And Work Experience

• Master’s degree or PhD in biostatistics or statistics
• 15+ years of biotech/pharma experience as a biostatistician
• Demonstrated experience supporting pivotal and registrational clinical trials
• Strong CRO and vendor oversight experience
• Track record of delivering high quality statistical related deliverables
• NDA/BLA experience

Additional Attributes

• Excellent knowledge of SAS
• Experience with sample size calculation software such as nQuery, EAST, etc.
• Knowledge of R a plus

Pay

$225,000 to $260,000 depending on education and relevant work experience