Roles and responsibilities: 1) Primarily responsible for quality and timely delivery of SDTM and ADaM artifacts (Specifications, datasets, cSDRG, 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 Skill Set - 1)Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials. 2) Experience creating and working with Utility Macros 3) Experience creating specifications 4) Experience with CDSIC standards including CDASH or SDTM/ADaM 5) Ability to work independently and as part of a team 6) Being open to new learnings and sharing with team members 7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 8) Proficient in using SAS EG/Studio for programming 9) Familiar with Unix environment and programming 10) Familiarity with multiple statistical procedures and functions to create TFLs Show more Show less

Experience Range: 8 – 14 years About the Role Primarily responsible for quality and timely delivery of CP reports (Data Validation Listings, Reconciliation Reports, Coding Review, CRF Metrics, Patient Profiles and Narratives). Thorough understanding of End-to-End Drug Development Process. Good data understanding and Analytical skills. Keen knowledge on Data Management and Data cleaning process and willingness to work for adhoc requests. Having a skill set of Database Knowledge and flow, Study Protocol, CRF Design, Coding Dictionaries, Central vs Local lab concepts. Experience in debugging system level macros and modifying them for study level. Develop utility macros for reusability and efficiency. Coordinate work on multiple projects according to priorities. Communicate with project team/stakeholders/other departments and/or groups effectively. Responsibilities Ability to program with and without specifications Reviewing and providing feedback on specifications when client provides them Ability to develop Macro from scratch or update existing macros Client Level Interaction not restricted to cascading work but setting up a project Ability to work independently and as part of a team Being open to new learnings and sharing with team members Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] Proficient in using SAS EG/Studio for programming Familiar with Unix environment and programming Experience with additional programming languages (R/Python, Spotfire) will be an added advantage. Qualifications Post-graduate degree in statistics, computing, life science related field B.E/B tech Required Skills Good data understanding and Analytical skills. Preferred Skills Experience with additional programming languages (R/Python, Spotfire) will be an added advantage Equal Opportunity Statement We are committed to diversity and inclusivity. Show more Show less