Director, Biostatistics & Data Management The primary focus of this position is clinical trials methodology and data, planning and performing statistical analysis of clinical trials. The position will work on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables. This position will participate in corporate development of methods, techniques, and evaluation criteria for projects, programs and people. Primary Responsibilities: Establishing and coordinate goals for department, coordinate and prioritize across trials and within the department, ensure ongoing employee training to enhance the skills and expand the knowledge of direct reports. Oversee the outsourcing of Data Management and Biostatistics to CROs, to develop positive partnerships with CROs and ensure a high standard of deliverables is maintained. Establish and examine procedural infrastructure including: existing working processes and methods, and development of new processes and methods as needed. Plan and perform statistical analysis for clinical trials. Provide statistical, clinical trial methodology, and regulatory input (e.g., trial design, sample size estimation, randomization, statistical methods, and query checks for clinical trial data). Contribute to CRFs and edit specifications. Review protocols and clinical study reports for consistency and accuracy. Produce detailed statistical analysis plans for clinical trials as well as for integrated summaries of efficacy and safety. Responsible for the management and analysis of clinical trial data, provide statistical input into the reporting of clinical trial results, and clearly communicate statistical results and concepts to non-statisticians. Participate in interactions with regulatory agencies as required. Responsible for in-house SOPs to support Data Management and Biostatistical activities. Job Qualifications: Ph.D. in Statistics/Biostatistics with at least 10 years of related experience or MS with a minimum of 10 years related experience in pharmaceutical/biotech setting. Previous Management or project experience is required. Broad experience in clinical statistics, data management, and SAS programming are required. Previous experience in preparing a NDA, CTD, or eCTD. Excellent team skills and written and oral communication skills. Strong ability to handle multiple projects simultaneously. Capable of representing the Company in statistical discussions with the FDA and other major regulatory authorities worldwide. Oncology experience is preferred. Submit Resume >> | Return to Careers >>