1. Primarily responsible for quality and timely delivery of ADaM artifacts (Specifications, datasets, ADRG) and TFLs
2. Read and understand Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents.
3. Develop SAS programs to produce Analysis datasets, statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP)
4. Develop validation programs to validate outputs produced by other team members and perform validation on program code of other team members.
5. Provide support to Data Management in developing Edit check programs, listings or ad hoc reports as required
6. Develop, Debug Utility macros for reusability and efficiency

Customer & Delivery Management

1. Support & Supervise Programming team towards resolving study/program related issues and thereby efficiently meet all project timelines & deliver quality outputs.
2. Respond to queries raised by sponsor/regulators
3. Communicate with project team/stakeholders/ other departments and/or groups effectively

Skills -

Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials.Experience creating and working with Utility MacrosExperience creating specificationsExperience with CDSIC standards including CDASH or SDTM/ADaMAbility to work independently and as part of a teamBeing open to new learnings and sharing with team membersExcellent communication skills [Written, Verbal, Interpersonal and organizational skills​]Proficient in using SAS EG/Studio for programmingFamiliar with Unix environment and programming​Prior working experience in Vaccines or Oncology is an added advantageFamiliarity with multiple statistical procedures and functions to create TFLs