San Diego, California, United States
• Accountable for all programming deliverables globally for Programs within their remit, including ensuring correct data standards are used, selection of quality risk indicators, and adequate resources available • Ensure work carried out by or on behalf of the Statistical Programming and Analysis group is in accordance with applicable SOP’s and working practices • Ensure all programming deliverables are inspection ready and acts as a key programming contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups within Pfizer. • Manage Significant Quality Events (SQEs) • Build and oversee a high performing team of statistical programmers to deliver clinical trials outputs and expertise to Research/Business Units and other Global Product Development lines in a high quality and timely manner • Responsible to drive cross functional strategic, scientific and technical data deliverables at the asset level • Define and drive the statistical programming strategy and standards for the Therapeutic Areas (TA) as well as industry data standards, tools and reporting • Drive cross-functional discussions to align on data strategies at the Program level to ensure successful regulatory submissions • Develop creative solutions to complex problems within and beyond scope of expertise (e.g. TA, discipline, department) • Establish strong partnerships with BU/RU, department leadership and other functions to advance asset or indication goals
• Line management responsibility for a team, including performance management and development activities, disciplinary procedures and administration activities. • Responsible for managing statistical programming activities on Phases I through IV multi-study clinical programs, ensuring completion on schedule, within budget and of high quality. • Providing ongoing supervision, advice and consultation to the Lead Programmers on complex projects within the USA and international offices. • Performing all tasks associated with the processes for which the Statistical Programming group is responsible. This includes preparation and review of Programming Plans, review of Statistical Analysis Plan, Case Report Forms, Data Management Plans and study related documentation. Development and review of SDTM\ADaM specification, SAS programs and outputs. • Leading support on data and submission standards to project teams to ensure high quality and timely eSub deliverables that meet industry standards and regulatory requirements (e.g., tabulation and analysis datasets, Define.xml development, CRF annotation, SDRG, ADRG, use of Pinnacle 21, SDTM compliance rule violation resolution, etc.). • Review of external vendor’s specifications and datasets to ensure compliance to CDISC implementation guidelines and standards. • Participation in the development and review of Global Biostatistics policies, manuals, standard operating procedures, data standards and other controlled documents. • Performing interviews, skills evaluation and selection of statistical programming candidates. • Support the activities of the business development group by providing costings and assumptions and input into presentations to clients. • Representation of Statistical Programming department at client meetings and during internal and external audits
• Design and development of Operations Support System/Business Support System for telecommunication operators. • Responsible for a wide range of activities from requirements analysis through design specification. • Collaborating with business analyst, designers and testers to translate client's business requirements into specific system, application, and process designs. • Coordination with the testing team in problem analyze including testing, designing, realization and validation of solutions.
• Development, implementation, utilization and improvement of electronic data capture system (EDC) for Clinical Research Projects. • Design and implementation of custom reporting systems for financial analysis and for human resource department. • Tuning and optimizing current and new applications. Integration of Microsoft Office products (Word, Excel) with application programs. • Working with Biostatistics and Data Management Department in preparation of specifications and documented results for the design and development database objects. • Coordination with Clinical Research, Data Management and Testing Team in preparation of validation plan and validation systems. • Providing consultations and training sessions to database users.