Senior Director, Biostatistics

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Requirements:

• PhD in Biostatistics/Statistics or equivalent with a minimum of 10 years relevant experience, or MS in Biostatistics/Statistics with a minimum of 15 years relevant experience.
• Extensive experience with IND/NDA activities and regulatory interactions.
• Experience with interim analysis design and data monitoring committees.
• Broad knowledge of medical/biological terminology in relevant therapeutic areas.
• Excellent SAS programming skills, including SAS/BASE, SAS/STAT, SAS/GRAPH, and SAS Macros.
• Ability to perform simulations in programming languages such as SAS or R.
• Knowledge of GCP/ICH guidelines for clinical trials.
• Pharmaceutical experience with clinical trials and regulatory agency expectations.
• Effective communication skills in explaining methodology and analyses.
• Ability to manage multiple projects and adapt to changing priorities.
• Strong motivational skills to ensure productivity and operation.

Responsibilities:

• Provides statistical leadership and support for all clinical development activities.
• Applies innovative statistical approaches to study designs and analyses.
• Ensures accuracy of biostatistics deliverables in protocols and regulatory documents.
• Coordinates achievement of statistical deliverables across multiple clinical trials.
• Leads management of biostatistics resources and collaborates for timely deliverables.
• Monitors project progress and allocates resources effectively.
• Provides statistical leadership for marketing applications to regulatory agencies.
• Collaborates to develop standard processes for compliant data sets.