Senior biostatistician (Durham, NC, Cincinnati, OH, Northbrook, IL, Thousand Oaks, CA, Wilmington, NC, Old Lyme, CT & Cranford, NJ).(Biostatisticians)

Kendle International, Inc: Develop and implement statistical analysis plans, protocols, study reports, and other statistical sections of NDAs and other drug, device, or biologic regulatory submissions. Participate in the project specific programming of statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs) set forth by Kendle and its sponsor clients. May supervise limited numbers of biostatistics staff.

Essential duties and responsibilities: Efficiently and effectively coordinate statistical reporting activities for multiple projects simultaneously. Serve as primary statistical oversight for medical data science standalone or otherwise complex studies. Provide leadership and motivation to departmental personnel. Develop and review statistical analysis plans based on study specific documents and sound statistical methodology. Develop, maintain, and produce statistical programs and specifications used in creating analysis datasets, tables, listings, and figures. Ensure the efficiency, quality, and integrity of data reporting, project and supervisory activities executed. Assist in the marketing and proposal development activities of the department. Actively monitor project budgets and help staff identify resourcing or scope of work changes. Provide accurate and timely status updates to other team members, colleagues, and senior management. Successfully represent department and company in a multi-disciplinary setting, such as project teams, project meetings, and client meetings/presentations. Maintain a positive working relationship with clients. Interact collaboratively with other departmental staff to ensure that project and department activities are successfully completed. Advocate the departmental team approach for effective management of broad based projects such as NDA submissions or ...