Senior Biostatistician

Job Description: The Biostatistician is responsible for providing the statistical expertise for company products within one or more therapeutic areas. This role will lead protocol development, analysis plans and file/report specifications, and review study setup activities including but not limited to randomization, CRFs and data edits and serve as lead biostatistician for assigned project(s). You will perform statistical analyses, interpret statistical results, and prepare clinical study reports including integrated summaries for submissions as appropriate.

• Represent Biostatistics on Project Teams; provides statistical expertise to support clinical development objectives and strategy
• Define statistical methodology, analyzes data, and reports results and contributes to the strategic planning and execution of the clinical development plan for the assigned project (e.g. statistical consideration of synopses or protocols, statistical analysis plans, etc.); ensures the quality of their deliverables.
• Assist responses to addressing statistical issues are part of regulatory, legal, or other challenges to the company’s products or processes; may represent Biostatistics in key meetings as assigned
• Serve as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel, and acts as an internal consultant, as assigned, on broad statistical issues that impact on the pharmaceutical/Biotechnology industry
• Participate in approved process improvement initiatives.
• Conducts modelling and simulations as needed
• Promote the use of innovative statistical methodology approaches by identifying, adapting, developing, or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Biometrics department through her/his expertise and customer orientation.
• Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials

Preferred Experience:

• Experience in statistical or biostatical analysis supporting clinical trial operations for the pharma/biotech industry
• Past regulatory interactions preferred
• Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them.
• Ability to develop innovative/creative statistical/technical solutions to complex problems.
• Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies.
• Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas.
• Proficient with SAS, S-Plus/R, Sample size calculation software (e.g., East, PASS, NQuery)
• Knowledge of CDISC data standards
• Ability to write statistical code and documentation