Junior Statistical SAS Programmer

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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 (according to ICH E3), publications, or Health Authorities requests. The role involves collaborating with Biostatistics and Data Management staff on clinical trials and projects.

Key Responsibilities:

1. Develop SAS programs for generating datasets, tables, figures, and listings for clinical trials, publications, and Health Authorities requests.
2. Utilize CDISC guidelines to generate SDTM/ADaM datasets.
3. Write programming specifications for analysis datasets.
4. Validate ADaM datasets using Pinnacle 21.
5. Prepare, maintain, and archive CDISC documentation for ADaM (Define.xml and ADRG).
6. Contribute to developing standard SAS macros and validation documents.
7. Liaise with Data Management team to develop SAS programs/macros and utilities to detect data discrepancies.
8. Develop SAS programs to import and reconcile external clinical data.
9. Create and validate SAS programs for identifying Non-Protocol Deviations.
10. Collaborate with Biostatistics and Data Management teams on clinical trials and projects.
11. Maintain SAS programming documentation.
12. Assist in establishing and maintaining SOPs, forms, and templates related to SAS programming.
13. Stay informed on new SAS developments relevant to clinical data management and update the Direct Manager accordingly.
14. Ensure KPIs and metrics for assigned studies are met.
15. Complete required trainings on time.
16. Accurately record daily work hours in the TRACK system.
17. Perform additional tasks as assigned.

Qualifications:

• Minimum of 1 year of experience in CRO, biotech, pharma, or research institutes in a similar role is preferred.
• Knowledge of HA requirements related to pharmaceutical research and SAS programming.
• Understanding of statistics and its application in clinical trials.
• Proficiency in SAS and CDISC standards (SDTM, ADaM).
• Strong planning and organizational skills.
• Team-oriented attitude.

What We Offer:

We provide a competitive salary, bonuses, and other benefits, along with opportunities for professional growth within an expanding international company.

Additional Information:

Please review the personal data processing notice available on our company website.

About Us:

OPIS is an international CRO with 25 years of experience in conducting Phase I-IV, non-interventional, and medical device studies worldwide. We leverage cutting-edge technology and innovative approaches to meet the increasing complexity of projects, offering comprehensive clinical research services across all trial phases.

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