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Senior Clinical Programmer Technical Lead

Bengaluru, KA
Job Code:
  • Biotechnology & Science
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Job Details

Job ResponsibilitiesResponsible for implementation and execution of high quality clinical programmingDemonstrates strong understanding of ICH guidelines, as applicable to clinical programmingCreates programming training exercises, trains new programmers, and serves as mentorTrains via self-study and self-practice independently and explores advanced topics related to clinical programming and/or drug developmentUtilizes System Development Life Cycle (SDLC) for programming deliverablesInteracts directly and independently with client to coordinate all facets of the project; competent communicatorWorks with statistical personnel to provide definitions, documentation and review of derived variables needed to produce planned tables, listings, and graphsGenerates tables, listings, and graphs from clinical trial databases using SASDevelops programs, verifies, validates, and maintains clinical trial databases and data entry screen using SAS and related softwareDevelops data and programming specifications jointly with other programmers and biostatisticiansDesigns specific data presentations including creative summary tables, graphs, and patient listingsAssists with preparing data validation plan based on client needsDevelops clinical programming efficiencies based on broad, in-depth knowledge of proceduresFollows processes related to project management as appropriate for programming projects (e.g. updating PSS, close-out procedures etc)Demonstrates extensive knowledge of departmental processesDesired Skills and ExperienceAt leastsix years' work experience in programming role, preferably supporting clinical trials/ or in the pharmaceutical industry)Masters in Mathematics, Statistics/ Computer Science of Health Science graduatesWork from home available across IndiaAdvanced knowledge of/ experience with SAS and other relevant programming softwareHas high level knowledge of drug development as it pertains to clinical programming; has the ability to apply drug development knowledge during production of high quality programsProven experience leading programmer support for multiple clinical trials and submission activities (or equivalent)Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP. ICH)Strong experience with data and production of TLGsThorough understanding of CDISC standards and HL-7 standardsExperience in pharmaceutical or CRO industryProven experience in development of advanced MACROs with high programming efficiency;Working knowledge of database design/ structures and basic statisticsWorking experience in pooling analysis datasets across multiple clinical studies (or equivalent)Familiarity with ISO 90012008 requirements
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 6-8


Application Programming | Software Engineer
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