Will be responsible for being a technical resource and mentor to other statistical programming analysts. Will lead technology and process initiatives and design/development global utilities and macros. Provide expertise and hands on support to clinical projects across multiple therapeutics areas. Contribute in Building Statistical Programming Infrastructure. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Will typically have IC and MGMT staff reporting into this level.
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgments within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules and performance requirements are met. Work with IT ensuing that local IT infrastructure meets Biometrics needs and global standards. Adhere to principles of GCP and develop, apply and promote consistent programming standards through standard processes and SOPs. Identify areas of deficiency requiring SOPs or guidelines and develop and execute a plan to rectify. Administratively and functionally manage statistical programmers with respect to statistical programming strategy, deliverables, processes, and professional development. Lead data standardization efforts (SDTM, ADaM, and Define.xml) per CDISC, EMA/FDA submission requirements. Ensure safety reports are following the standards and are consistent across compounds or studies. Provide timeline and resource forecasts for statistical programming deliverables. Mentor statistical programmers on team performance and relevant therapeutic areas. Hiring of additional staff. Responsible for processing of clinical data required for analysis of clinical trials for Phase 1-4. Initiate programming environment. Develop SAS coding and table templates for preparing, processing and analyzing clinical data. Create/acquire tools to improve programming efficiency and quality. Validate work of other programmer/analysts at CROs or in-house. Perform vendor qualifications. Manage CROs regarding programming issues and activities to ensure timely delivery of tables and data listings.
Provide guidelines, review, and QC CRO deliverables to ensure the quality of deliverables. Participate in the lead task forces and new initiatives, while maintaining current knowledge of programming practices and development within the industry. Work with other functional groups to identify areas where statistical programming support can enhance efficiency and quality.
Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues. Ensure SOPs have been developed properly. Ensure statistical programming tasks has been conducted in a compliant and timely manner with high quality across all projects. Ensure the computer system and network are set up appropriately. Administratively and functionally manage statistical programmers with respect to statistical programming strategy, deliverables, processes, and professional development.