Lead Mapping Programmer

Jobbeschreibung

Schweiz
Merck Sharp & Dohme (MSD)
03.05.2024
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Job DescriptionPrimary activities include, but are not limited to:Assumes the responsibilities for all data mapping deliverables including SDTM structure set-up and transformation maps to support multiple clinical programs. Coordinates and participates in the following activities:30% Design, build, maintain, test, and document data mapping specifications based on clinical database structures establish by Global Clinical Data Management and Clinical Research.  Mapping specifications must meet SDTM structure requirements utilizing DMW and E2E visibility tools to ensure quality and timeliness of data flow to the Clinical Data Repository.  Review the technical feasibility needs for transformations and technically implements them in support of the Business Rules required for SDTM compliance and the Clinical Data Repository in support of Analysis and Reporting performed by Scientific Programming of study team proposed reports. Work effectively among RaM Mapping team to communicate issues and ideas to improve the business.30% Support the standard library development for data mapping to the clinical data repository including support of the business rules utilized for Analysis and Reporting and transformations to verify data transfer between and across the various databases among data collection, reporting, and the data repository.15% Under proper change management, responsible for change requests and incidence correction into clinical database. Ongoing support in a dynamic and matrix organization.  25% Participate in extra activities including, but not limited to, study improvement task forces, automations, initiatives, testing of new systems, and ongoing training and mentoring.RequirementsEducation:At least B.A. or B.S. degree, preferably in mathematics, science, a health care related discipline, or computer science.Knowledge and Skills:5+ years’ experience withCDISC Standards, (SDTM, CDASH, Define.xml)SAS/R/Python/PLSQLSolid knowledge of Clinical Database Development/Reporting toolsSolid knowledge of System Development Lifecycle Management / system validation knowledge Solid knowledge of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11. Solid knowledge of database structures and available tools to manage, extract, report and warehouse data.  Strong communication skills (oral and written) with the ability to communicate with both the technical and business areas. Strong organizational and problem-solving skills. Ability to work cross functionally and as part of a team.Able to work independently, under pressure and change environment with flexibility.Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: RegularRelocation:No relocationVISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Not ApplicableShift:Valid Driving License:Hazardous Material(s):SummaryLocation: CHN - Beijing - Beijing (Wangjing Park)Type: Full time