Farmaceutica jobs in Italy

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.

1. Developing SAS programs for datasets, tables, figures, and listings for clinical trials, publications, and regulatory requests.
2. Using CDISC guidelines to generate SDTM/ADaM datasets.
3. Writing programming specifications for analysis datasets.
4. Validating ADaM datasets with Pinnacle 21.
5. Preparing and maintaining CDISC documentation such as Define.xml and ADRG.
6. Contributing to the development of standard SAS macros and validation documents.
7. Liaising with Data Management to develop SAS programs and macros to identify data discrepancies.
8. Handling external clinical data import/reconciliation through SAS programming.
9. Developing and validating SAS programs for identifying Non-Protocol Deviations.
10. Collaborating with Biostatistics and Data Management teams on projects.
11. Maintaining SAS programming documentation.
12. Assisting in establishing and maintaining SOPs and documentation standards.
13. Staying informed on new SAS developments relevant to clinical data management.
14. Ensuring KPIs and study metrics are met.
15. Completing required trainings on time.
16. Accurately recording time in the TRACK system.
17. Performing additional assigned tasks.

• 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 in clinical trials.
• Proficiency in SAS and CDISC standards (SDTM, ADaM).
• Strong planning and organizational skills.
• Team-oriented mindset.

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

OPIS is an international CRO with 25 years of experience in conducting Phase I-IV, non-interventional, and medical device studies worldwide. We utilize state-of-the-art technology and innovative approaches to manage complex projects. Our expertise spans all phases of drug trials, supporting sponsors beyond therapeutic areas, including clinical investigations for medical and diagnostic devices. With global locations, we offer comprehensive clinical research services such as scientific advice, medical writing, trial start-up, monitoring, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture, quality assurance, and training.