Senior Statistical Programmer

3 weeks ago

South Plainfield, United States Katalyst Healthcares and Life Sciences Full time

Roles & Resonsibilities:

  • We are looking for an associate with at least 5+ years of experience for Sr Statistical programming position, having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards.
  • SDTM/ADaM Model and IG.
  • Thorough understanding of SDTM/ADAM concepts and challenges. Good hold on the TAUG's and related guidelines.
  • Hands on experience in implementing SDTM/ADAM concepts across TA's and various phases of clinical trains. Good understanding on previous versions on SDTM/ADAM guidelines.
  • Study Reporting.
  • Suggest creative solution approach for various business requirements to solve complex SDTM/ADaM Mapping and Programming problems (e.g. creates modular reusable code, develops standard code or utilities, and designs interconnected programs.
  • Review and author documents related to deliverables (User Guide, CDARS Mapping Specification, OCF, Test Plans, SAS Logs and Programs).
  • Good understanding of all study documents including Protocol, SAP, Mock Shells, LOT, Analysis plan etc.
  • Hands on experience of development and review of study specific tables, listings and figures for various phases of clinical trials and across TA's.
  • Expertise in Base and Advance SAS programming.
  • Expertise in developing macros and developing generalized programs.
  • Development of the complex SAS macros that can be utilized across TAs in multiple studies; review of the developed SAS programs.
  • Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS and other advanced SAS components.
  • Mentor and supervise developer to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements.
  • Controlled Terminology
  • Good understanding of code list and value list concepts. Expertise in managing NCI codelist and tracking its updates. Exposure to CDASH, SDTM/ADaM and ADaM lineage concepts
  • Other CDISC IG's
  • Exposure to Medical Device, Associated Patients, Oncology and other specific guidelines around CDISC SDTM/ADaM.
  • Hands on exposure in managing few of these activities
  • Developing Mapping Specs
  • Hands on experience in developing mapping specs for SDTM/ADaM. Desirable to have hands on experience in developing mapping specs for a TA or global level SDTM/ADaM mappings.
  • Senior Statistical Programmer is responsible for review of developed SDTM/ADaM mapping specifications
  • SDTM/ADaM Dataset Programming
  • Hands on experience in generating SDTM/ADaM datasets using SAS programming or other tool-based approach.
  • SDTM/ADaM Compliance Define
  • Hands on experience generating define.xml files, experience in performing SDTM/ADaM compliance checking using P21 or other compliance checks.

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