Technical Lead Statistical programmer

Job Title: Tech Lead – Statistical ProgrammingDepartment: Clinical Analytics/Project Based ServicesLocation: Bangalore, Remote, IndiaJob ResponsibilitiesWorks 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 studiesDevelop 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 utilitiesDevelop and/or validate SAS programs to generate SDTM, ADaM datasets and TLFs to ensure regulatory complianceDevelop 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 activitiesDevelop utility macros for reusability and efficiencyExperience on e-submisssion packages like SDRG, ADRG, Define.xmlGood Exposure on ISS and ISESupport & 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/supportProvide programming input to CRF and External DataCompliance to regulatory requirementsCommitment 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 QualificationMinimum 6 years of experience in Statistical programming DomainProficient in SDTM/ADaM/TLFExposure to work on clinical trials pertaining to at least one Therapeutic area would be preferrableExperience 6.1 – 8 Years

Apply Now