Manager, Statistical Programming

General Summary
The Manager of Statistical Programming will manage a team of statistical programmers engaged in medical device clinical research activities. The Manager of Statistical Programming provides statistical programming support for multiple projects through own efforts and those of staff for assigned projects. The manager builds relationships and promotes collaboration across functions with internal colleagues in Statistics, Data Management, Scientific Communications, Regulatory Medical Writing, and Clinical Study Management. This individual is responsible for ensuring the quality, integrity, and timely delivery of programming deliverables supporting clinical studies, publications, and regulatory submissions. The role drives programming standards, process improvements, innovations, and continuous improvement.
 
Specific Duties and Responsibilities
•    Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. *
•    Lead a team of statistical programmers. Attract, recruit, hire, and retain new staff.*
•    Lead resource planning for statistical programming team, including forecasting of employees and external resources (contractors, temps, CRO, consultants). *
•    Oversee team effort related to derive data sets and programs, and analysis data set specifications. *
•    Ensure consistency analysis of data sets following appropriate standards for clinical studies. Ensure consistency within a therapeutic area.
•    Develop and oversee the development of statistical code for the creation of Tables, Listings and Figures for clinical studies. *
•    Ensure that all quality processes are followed. Determine the scope of code verification and ensure completeness of verification for assigned projects. *
•    Provide input into the development of CRFs and database designs, and definitions. Participate in the development of CRFs, edit check specifications, and data...