Clinical SAS Programmer Job in Telecommute
Senior Statistical Programmer
Title: Senior Statistical Programmer
Department: Biostatistics Clinical Programming
Employment Type: Full Time
KEY ACCOUNTABILITIES:
-Deliver best value and high quality service
-Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming Coordinator will:
-Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
-Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget
-Monitor project resourcing, project budgets, and identify changes in scope
-Interact with Sponsors as the key contact with regard to statistical programming issues
-Provide technical support and advice to the internal team
-Check own work in an ongoing way to ensure first-time quality
-Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
-Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
-Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents.
-Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings.
-Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department.
-Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units.
-Create standard macros and applications to improve the efficiency of the department.
-Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance
-Be trained in sponsor WSOP’s and disseminate knowledge to project team members as appropriate.
-Proactively participate in and/or lead process/quality improvement initiatives
-Work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required
-Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.
-Maintain and expand local and international regulatory knowledge within the clinical industry
-Assist project teams in the resolution of problems encountered in the conduct of their daily work
-Provide relevant training and mentorship to staff and project teams
SKILLS:
-Proficiency in SAS
-Knowledge of the programming and reporting process
-Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
-Demonstrate ability to learn new systems and function in an evolving technical environment.
-Ability to successfully work together with a (¿virtual¿) team (including international teams as required) as well as independently
-Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change
-Business/Operational skills that include customer focus, commitment to quality management and problem solving
-Good business awareness/business development skills (including financial awareness)
-Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
-Demonstrate commitment to refine quality processes
-Effective time management in order to meet daily metrics or team objectives