Job Title

Job Title: Tech Lead – Statistical Programming Department: Clinical Analytics/Project Based Services Location: Bangalore, Remote, India Job Responsibilities Works on issues of limited scope. Follows established practices and procedures in analyzing situations or data from which answers can be readily obtained. Work is reviewed upon completion and is consistent with departmental objectives. Primarily responsible for quality and timely execution of SDTM, ADaM /TFL artifacts (Annotated CRF, Specifications, Datasets, Define.xml etc.) for assigned studies Develop and review specifications (Defines) and create/validate SAS programs for the mapping of raw datasets to CDISC SDTM, ADaM standards. Develop, debug, and maintain simple to moderately complex programs, macros, and utilities Develop and/or validate SAS programs to generate SDTM, ADaM datasets and TLFs to ensure regulatory compliance Develop validation programs to validate outputs produced by other team members and perform validation on program code of other team members. Act as a primary point of contact for SDTM, ADaM/TFL programming activities Develop utility macros for reusability and efficiency Experience on e-submisssion packages like SDRG, ADRG, Define.xml Good Exposure on ISS and ISE Support & Supervise Programming team towards resolving study/program related issues and thereby efficiently meet all project timelines & deliver quality outputs. Mentor and evaluate team members to establish training and coaching needs. Assist in training for new resources and as a part of continuous improvement. Participate in study/project team meetings as a core member and provide technical expertise/support Provide programming input to CRF and External Data Compliance to regulatory requirements Commitment to compliance with Integrated management system which includes standards like ISO 9001, 27001, 22301 and any new standards that the organization plans to implement. Participate in the trainings organized for these applicable standards./" Qualifications & Certifications Education Qualification Graduate/ post-graduate degree or equivalent in Statistics or Biostatistics or Mathematics or Computer science Or Pharmacy Professional Qualification Minimum 6 years of experience in Statistical programming Domain Proficient in SDTM/ADaM/TLF Exposure to work on clinical trials pertaining to at least one Therapeutic area would be preferrable Experience 6.1 – 8 Years