Provides leadership within biostatistics function to develop and execute statistical strategy, design and analyses for clinical trials in all phases.
Requirements
- BS/BA degree in Statistics/Biostatistics or related discipline and a minimum of thirteen years of related experience
- MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of eleven years of related experience
- PhD in Statistics/Biostatistics or related discipline and a minimum of eight years of related experience
- Comprehensive and detailed knowledge of statistical experimental designs, analyses and clinical trial requirements
- Developed/reviewed SDTM/ADaM specifications
- Excellent knowledge of FDA/EU statistical guidelines
- Management and statistical analysis of data obtained from Phase I – IV studies in support of NDAs
- State-of-the-art data organization and statistical analyses using statistical software such as: SAS, EAST, nQuery, Cytel Studio
- Project management and contract negotiation with outside vendors
- Strong analytical and business communication skills
Benefits
- Comprehensive employee benefits package
- 401k plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Sales-based incentive plan
- Opportunity to purchase company stock
- Long-term incentives
- 15 accrued vacation days in their first year
- 17 paid holidays including a company-wide winter shutdown in December
- Up to 10 sick days throughout the calendar year