Manager of Statistical Programming

Manager of Statistical Programming, IQVIA RDS Inc., Durham, NC. Multiple Openings. Telecommuting from anywhere in the U.S. accepted. Supervise individual contributors engaged in statistical programming activities. Conduct code review on direct reports to get a sense of employees’ abilities, strengths, and weaknesses, and work with those individuals to improve upon weaker areas. Translate study protocol and Statistical Analysis Plan into algorithms and specifications to achieve analysis and CDISC standards. Ensure that self and staff are compliant with training requirements. Create and/or validate safety and efficacy study output requirements (e.g. SDTM, ADaM, TLFs, etc.) consistent with data definitions and specifications and relevant study documentation (e.g. protocol, SAP, aCRFs, etc.). Oversee the implementation of Pinnacle 21 checks and resolutions. Review vendor-provided SDTM datasets for adherence to established company and industry standards as well as communicating with the vendor to resolve discrepancies. Communicate an understanding of statistical programming concepts, basic clinical principles and act in accordance with those principles. Review for consistency across studies within a project; assist with developing project conventions and verifying that conventions are followed. Provide accurate and timely responses to routine requests from clients and responses to non-routine requests from clients. Assist with accuracy of database and development of database checks for routine situations and development of checks for non-routine situations. Manage the maintenance of programming specifications for SDTM, ADaM, analysis datasets, analysis outputs, and integration of data in support of ISS/ISEs. Develop and provide department training for applications and standard tools. Responsible for identifying opportunities for productivity improvements and formulating proposal for new SAS utilities/macros and their implementation. Serve as SME advising Biometrics leadership on promoting data quality through various software technologies, programming tools, and techniques, data standards, as well as process improvement in support of clinical data cleaning, review, and monitoring activities. Responsible for formulating proposals for new utilities and/or tools as well as presenting information on existing utilities and/or tools. Responsible for developing and maintaining good client relationships. Guide clients on possible options for deliverables for non-routine requests. Train and/or mentor new statistical programmers on statistical programming practices. Provide performance management assessments for all direct reports. Communicate with client project leads to get feedback on direct reports and project health. Provide input and review status of project and/or departmental budgets.