Clinical SAS Programmer

3 weeks ago

Ahmedabad, India CBCC Global Research Full time

Dear Candidate,

Below are the Job Details for Clinical SAS Programmer role at CBCC Global Research LLP.

Candidate should have the exposure of SDTM, ADAM and TLF.

  • Job Location : Ahmedabad At Office
  • Position : 2
  • Experience: 2-5 years in CRO preferred / Pharma industry
  • Qualification : M. Sc. Statistics/Any Science Graduate
  • Mandatory experience in Clinical trials

Responsibilities:

Ensure consistently high quality outputs for reporting and submission-

1.1. Build SAS datasets from clinical database.

1.2. Develop SAS macros, templates and utilities for data cleaning and reporting.

1.3. Utilize SDTM guidelines to build datasets.

1.4. Communicate with an internal team to create deliverables for pharmaceutical and biotechnology clients.

1.5. Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician.

1.6. Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy.

1.7. Write SAS programs to generate tables, listings, and figures and analysis datasets.

1.8. Review CRF annotations and data specifications.

1.9. Work in tandem with Biostatistics and Data Management member on various clinical projects.

1.10. Identify and edit checks per the data validation plan or data management plan.

1.11. Study management reports using SAS.

1.12. Validate the programmed analysis datasets, tables, listing and figures.

1.13. Perform analyses defined in the statistical analysis.

1.14. Prepare clinical and statistical summary reports.

1.15. Communicate with programming and statistics leads.

1.16. Utilize SAS programming skills within protocol team and perform all programming required for clinical trial analysis and reporting.

1.17. Perform quality control on final reports.

1.18. Develop SAS coding and table templates for preparing, processing and analyzing clinical data.

1.19. Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.

1.20. Provide input as required at all meetings, discussions and activities covering aspects of Statistical Reporting on project level activities.

1.21. As required, make certain that documents and specifications are consistent and comply with company standards for specifications of analysis datasets, listings, summaries, figures and tables for the clinical project

1.22. Program, according to specifications, analysis datasets, listings, tables, and figures for clinical projects and/or apply standard statistical methods to standardized PK study designs

1.23. Track milestones for project deliverables.

1.24. Maintain records for all assigned deliverables including archiving of project analysis and associated documentation.

1.25. Comply with pre-defined project / study standards and specifications.

1.26. Validate the programmed analysis datasets, tables, listing and figures. Utilize SAS programming skills within protocol team and perform all programming required for clinical trial analysis and reporting.

1.27. Develop SAS coding and table templates for preparing, processing and analysing clinical data.

1.28. Begins to develop a working knowledge of drug development and approval process

1.29. Other duties as assigned by reporting head or management

Perks and Benefits

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