Statistical Programmer - SAS, SDTM, ADAM, TLF - 4+ yrs - CHENNAI GSN Consulting

4.0 - 9.0 years

15 - 20 Lacs

Chennai

Work from Office

Hi, Wishes. Pleasure connecting with you. Job Summary: We are hiring mid-level Statistical Programmers (4 - 8 years of experience) with strong hands-on expertise in SAS programming for clinical trials. The role requires experience in SDTM and ADaM dataset creation, TLF programming, and knowledge of CDISC standards. You will be working on end-to-end programming activities for Phase IIV clinical studies. Mode of Work : WFO Exp Range : 4 to 8 yrs Work Location : CHENNAI CTC Range : Best in the industry ***** Looking for SHORT JOINERs ***** Key Responsibilities: SDTM Programming: Create and validate SDTM datasets as per CDISC guidelines. Perform CRF annotation and author/review specifications . Generate Define.xml and ensure compliance using Pinnacle 21 . Work on Study Data Reviewers Guide (SDRG) and submission packages. ADaM Programming: Develop ADaM datasets for Safety and Efficacy analysis. Write and validate ADaM specifications and ensure alignment with SAP. Prepare ADaM Define.xml and reviewer documentation. TLF Programming: Generate and QC Tables, Listings, and Figures (TLFs) as per SAP. Use SAS Graph and macros to build clinical outputs. General Programming & Project Work: Independently write or modify SAS programs from scratch or using templates. Develop or enhance custom macros to streamline programming tasks. Work in both production and validation programming roles. Handle multiple studies simultaneously , ensuring high-quality deliverables. Participate in integration and pooling (ISS/ISE) of datasets. Work on CRT packages and electronic submission readiness. Required Skills: Strong knowledge of SAS Base, SAS/STAT, SAS/GRAPH in a clinical trial setting. Solid understanding of CDISC SDTM and ADaM standards . Experience with Define.xml creation and validation tools like Pinnacle 21 . Hands-on exposure to multiple therapeutic areas and clinical phases . Experience in ISS/ISE and integrated datasets is a strong plus. Nice to Have: Familiarity with tools such as Define.xml Generator, SAS Clinical Standards Toolkit . Knowledge or EXP in R Programming is OPTIONAL Exposure to MACRO programming and reusable code frameworks . Understanding of regulatory requirements for FDA/EMA submissions . What We Offer: Projects with top global pharma clients. Work with a high-performing and collaborative clinical data team. Competitive compensation, learning, and growth opportunities. If Interested, click APPLY ONLINE for IMMEDIATE response. Best, ANANTH | GSN HR | 9840035825 | Google review : https://g.co/kgs/UAsF9W

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