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Sdtm-adam Programmer / Statistical Programmer _bangalore / Mumbai

Keywords / Skills : sdtm, adam, Stastical programmer, SDTM ADAM Programmer, SDTM Model, ADaM structure, Cdisc, define.xml, CRF, ectd, sas 9.4

4 - 7 years
Posted: 2018-06-13

Job Description
Good knowledge on SDTM model and SDTMIG. Hands on experience in- Creation of annotating CRF. Developing specification for SDTM domains including Trial design domains. Writing programs for SDTM domains using SAS 9.4 or above version. Validating SDTM datasets by using Pinnacle21 tool. Creating and validating SDTM define.xml by using Pinnacle21 tool. Responsible to create Study Data Reviewers Guide. Good knowledge on ADaM model and ADAMIG. Hands on experience in- Creation of ADaM Data definition table (DDT) with reference to protocol, SAP, DPP (mock shells) & CRFs. Programming of ADaM datasets (ADSL, BDS, and OCCDS) and validation by using Pinnacle21 tool. Creating and validating ADaM define.xml by using Pinnacle21 tool. Responsible to create Study Data Reviewers Guide. Responsible to create Analysis Data Reviewers Guide. Responsible to compile M5 folder structure of the Electronic Common Technical Document (eCTD) required for final NDA/ANDA submission. Salary: INR 8,00,000 - 14,00,000 P.A. Industry: Pharma / Biotech / Clinical Research Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology Role Category: R&D Role: Research Scientist Employment Type: Permanent Job, Full Time Keyskills: sdtm adam Stastical programmer SDTM ADAM Programmer SDTM Model ADaM structure Cdisc define.xml CRF ectd sas 9.4

About Company

Phoenix Human Capital Pvt. Ltd.Phoenix Human Capital Pvt Ltd., provides staffing solutions to over 70 clients across 41 verticals spanning across various IT and Non IT sectors. With proven strengths in sectors like IT, Telecom, FMCG/D, BFSI, Pharmaceuticals, Infrastructure, Health Care, Hospitality and EMPI, the organisation strengthens its relationships in the Industry through its innovative and professional solutions & services.


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