Full-Time Director of Biostatistics

Statistical Science Director provides highly experienced statistical, scientific and strategic support to the clinical and regulatory strategies across all phases of drug development.

Product Statistician: accountable for the overall quality and timely delivery of statistical analyses.

Responsibilities:

• Leading statistical thinking & contributions to plans.
• Providing leadership & project coordination.
• Accountable for statistical content.
• Coaching & developing less experienced statisticians.
• Providing leadership & project coordination for all statisticians.
• Providing statistical input to TPP & Target Labels.
• Providing statistical input to CDP design.
• Pro-active role in designing innovative studies.
• Approving CSPs & CSRs.
• Approving Statistical Analysis Plans.
• Preparing responses to regulatory questions.
• Providing input into outsourcing strategy.
• Collaborating with internal statisticians.
• Staying informed of developments in statistical methodology.
• Contributing to SOP development.
• Participating in SDRF reviews.

Qualifications:

• Bachelor of Science (BSc) in mathematical statistics, statistics or equivalent.
• 8+ years of experience as a statistician in the pharmaceutical industry.
• Leadership experience from project or line management.
• Extensive phase II, III & IV program experience.
• Clinical program & study design & data analysis experience.
• Major regulatory submission experience.

Skills:

• Comprehensive knowledge of clinical & pharmaceutical drug development
• Sound knowledge of theoretical & applied statistics
• Ability to find innovative approaches to trial design & analysis
• Sound understanding of the regulatory environment
• Excellent communication skills

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