Junior Statistical SAS Programmer

The Junior Statistical SAS Programmer, under the supervision of the Direct Manager, is primarily responsible for developing SAS programs to generate datasets, tables, figures, and listings for clinical studies in accordance with ICH E3 guidelines. The role involves collaboration with Biostatistics and Data Management teams on clinical trials and projects.

Key Responsibilities:

1. Develop SAS programs for generating datasets, tables, figures, and listings for clinical trials, publications, or Health Authorities requests.
2. Utilize CDISC guidelines to generate SDTM and ADaM datasets.
3. Write programming specifications for analysis datasets.
4. Validate ADaM datasets using Pinnacle 21.
5. Prepare, maintain, and archive CDISC documentation such as Define.xml and ADRG for ADaM datasets.
6. Contribute to the development of standard SAS macros and validation documents.
7. Liaise with Data Management to develop SAS programs, macros, and utilities for data discrepancy detection.
8. Develop SAS programs for importing and reconciling external clinical data.
9. Create and validate SAS programs to identify Non-Protocol Deviations.
10. Maintain SAS programming documentation and SOPs.
11. Stay informed on SAS developments relevant to clinical data management.
12. Ensure KPI and metrics are met and complete all required trainings on time.
13. Accurately record time in the TRACK system.
14. Perform other assigned tasks as necessary.

Qualifications:

• Scientific degree.
• At least 1 year of experience in CRO, biotech, pharma, or research institutes is preferred.
• Knowledge of HA requirements related to pharmaceutical research and SAS programming.
• Understanding of statistics and its application to clinical trials.
• Proficiency in SAS and CDISC standards (SDTM, ADaM).
• Fluent in English.
• Strong planning, organizational, and communication skills.
• Team-oriented mindset.

What We Offer:

A competitive salary, bonuses, and benefits, along with opportunities for professional development within a growing international company.

About Us:

OPIS is an international CRO with 25 years of experience in conducting clinical trials and medical studies globally, offering advanced technology solutions and comprehensive services across all trial phases.