Principal Biostatistician

We are seeking a Principal Biostatistician to serve as the overall statistical lead on one or more clinical programs and provide statistical input in design, analysis, and reporting of clinical studies. The role requires a strong statistical background, experience with SAS programming, and knowledge of regulatory guidelines.

Requirements

• Master’s degree in statistics or biostatistics, or a related discipline and 4+ years of experience in the design, analysis, and reporting of clinical studies
• Demonstrated ability to provide statistical leadership and strategic input regarding the overall drug development plan and commercialization activities
• Strong organizational skills and proven ability to effectively lead a project to successful completion
• Significant expertise in the design, analysis, and reporting of clinical studies
• Advanced knowledge of the SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data
• Advanced knowledge of working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets
• Thorough knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data
• Expertise in interacting directly with regulatory authorities highly desirable
• Maintains expertise in state-of-the-art data manipulation and statistical analyses
• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines

Benefits

• Retirement savings plan (with company match)
• Paid vacation
• Holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage