Senior Statistical Programmer
- Siro Clinpharm
- 7 - 12 years
- Mumbai
- 1 month ago
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Job Description
Topic
Details
SDTM/ADAM Model and IG
Thorough understanding of SDTM/ADAM concepts and challenges. Good hold on the TAUGs and related guidelines. Hands on experience in implementing SDTM/ADAM concepts across TAs 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, 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 TAs.
SAS Programming
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 IGs
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.
Validation
Implement QA and QC validation in accordance with Departmental SOPs for deliverables including:
- Formal study reports
- Data review
- Presentations
- Adhoc-requests
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Healthcare & Life SciencesRole Category: Healthcare & Life Sciences - OtherRole: Healthcare & Life Sciences - OtherEmployement Type: Full timeContact Details:
Company: Siro ClinpharmLocation(s): Mumbai
Keyskills: Adam Cdisc Statistical Programming Sdtm Tlf
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Siro Clinpharm
Incorporated in 1996, SIRO Clinpharm Private Limited is a Clinical Research Organisation supporting trials from Phase II to Phase IV and beyond post-launch of products. SIRO offers a range of services, from clinical operations to data services, data analytics and medical writing in compli...
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