Job Description

Purpose: The Associate Director - Statistical Programming takes lead during the development of data analysis plans in collaboration with statistical colleagues, physicians, and/or medical colleagues. The Associate Director - Statistical Programming is responsible for establishing a reporting database and for analyzing clinical trial data by working with clinical research associates/clinical development associates and project statisticians. In addition, the Associate Director statistician-computation will provide coaching and guidance to less experienced staff members. The job tasks listed below outline the scope of the position. The application of these tasks may vary, based upon current business needs. Statistical Trial Analysis Collaborate with other statistical colleagues and study personnel to provide input to statistical analysis plans. u2022 Assist in and/or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the data analysis plan, and conducting the actual analysis once a reporting database is created. u2022 Collaborate with data management in the planning and implementation of data quality assurance plans. u2022 Maintain proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods. u2022 Effectively justify methods selected and implement previously outlined analysis plans. u2022 Conduct peer-review of work products from statistical colleagues. u2022 Effectively utilize current technologies and available tools for conducting the clinical trial analysis. u2022 Utilize deep technical skills to drive solutions to complex design and analysis issues. u2022 Communication of Results and Inferences u2022 Collaborate with other statistical colleagues to write reports and communicate results. u2022 Responsible for assisting in the communication of study results via regulatory submissions, and manuscripts, as well as for communicating one-on-one with key customers. u2022 Assist or respond to regulatory queries working in collaboration with other statistical colleagues. u2022 Therapeutic Area and Systems Knowledge u2022 Understand relevant disease states in order to enhance the level of customer focus and collaboration. Regulatory Compliance Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes and training. People Related Ensure all direct reports have a Performance Management (PM) and Development plan in place. u2022 Conduct interim and final PM reviews to evaluate performance, business results, and impact. u2022 Provide appropriate input on consensus evaluation for merit increase and promotion activities. u2022 Contribute to the development of direct reports through administrative direction, coaching, mentoring, and timely feedback. u2022 Appropriately manage the workload of direct reports. u2022 Provide input on employee development, talent assessment, and succession planning activities. u2022 Encourage appropriate rewards for deserving individual/group performance and results. u2022 Ensure all direct reports are in compliance with company policies, procedures, and regulations. Business Related Perform appropriate staffing activities and support the training and integration of new and current staff. u2022 Ensure appropriate implementation/execution of personnel/resource management plans and priorities. u2022 Take lead in identifying the needs and the recruitment of staff to meet business plan. u2022 Take active role in capacity planning and business planning. Minimum Qualification Requirements: M.S., Ph.D., or equivalent experience u2022 Statistics, Biostatistics, Computer Science, or equivalent of field study u2022 At 6 years of experience in the pharmaceutical industry u2022 Proficiency in the SAS programming language u2022 Interpersonal/teamwork skills for effective interactions u2022 Technical growth and application with working knowledge of statistics and statistical software u2022 Self-management skills with a focus on results for timely and accurate completion of competing deliverable: u2022 Creativity and innovation u2022 Demonstrated problem solving ability and attention to detail u2022 Data analysis, technology, and systems expertise

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