CBCC Global Research is a renowned Contract Research Organization (CRO) providing comprehensive research services in the pharmaceutical and biotechnology industries. With a strong focus on delivering quality and efficient clinical trials, the company is looking for a Clinical SAS Programmer to join their Ahmedabad office.
Responsibilities in the Job:
As a Clinical SAS Programmer, the key responsibilities include:
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- SAS Dataset Creation & Reporting: Building SAS datasets from clinical databases, ensuring high-quality outputs for reporting and submission.
- SAS Macros & Templates Development: Developing SAS macros, templates, and utilities for data cleaning and reporting.
- SDTM Guidelines Application: Utilizing SDTM (Study Data Tabulation Model) guidelines to build datasets and ensuring compliance with clinical trial standards.
- Collaboration & Communication: Communicating with internal teams to create deliverables for pharmaceutical and biotechnology clients and working closely with project statisticians for statistical analysis.
- CRF Review & Consistency Checks: Ensuring the Case Report Form (CRF) meets protocol guidelines and checking data consistency and adequacy.
- Program Tables, Listings, Figures: Writing SAS programs to generate tables, listings, figures, and analysis datasets for clinical trials.
- Data Validation & Quality Control: Identifying data validation checks and performing quality control on final reports.
- Monitoring & Milestone Tracking: Monitoring data transfers for ongoing trials, identifying study conduct issues, and tracking milestones for project deliverables.
- Documentation & Archiving: Maintaining records for all assigned deliverables, including archiving project analysis and associated documentation.
Qualification Requirements:
- Educational Qualification: M.Sc. in Statistics or any Science Graduate.
- Experience: 2-5 years of experience in Clinical Trials, preferably in a Contract Research Organization (CRO) or Pharmaceutical industry.
- Mandatory Skills: Experience with SAS programming, particularly in Clinical Trials. Proficiency in SDTM, ADaM, and TLF.
Skills Needed:
- Strong proficiency in SAS programming (especially for clinical trial analysis and reporting).
- In-depth knowledge of clinical trial processes and statistical methods.
- Ability to develop and implement SAS macros, templates, and utilities for data reporting.
- Experience with SDTM guidelines and data validation.
- Strong communication and collaboration skills to work effectively with cross-functional teams.
- Ability to track milestones, maintain records, and ensure compliance with project specifications.
