puestos de Biotecnologia en Italia

The Junior Statistical SAS Programmer, under the supervision of the Direct Manager, is mainly involved in developing SAS programs for the generation of datasets, tables, figures, and listings for clinical studies (according to ICH E3), publications, or Health Authorities requests. Collaborates with Biostatistics and Data Management staff on clinical trials/projects.

1. Develop SAS programs for generating datasets, tables, figures, and listings for clinical trials (according to ICH E3), publications, or Health Authorities requests.
2. Use CDISC guidelines to generate SDTM / ADaM datasets.
3. Write Programming Specifications of 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 prepare the corresponding validation documents.
7. Liaise with Data Management team and develop SAS programs/macros/utilities to detect discrepancies in the data.
8. Check the requirements to handle external clinical data and develop SAS programs to import/reconcile external clinical data.
9. Develop and validate SAS programs for identification of Non-Protocol Deviations.
10. Collaborate with Biostatistics and Data Management staff on clinical trials/projects.
11. Prepare, maintain, and archive SAS programming documentation.
12. Contribute to establishing and maintaining SOPs and related templates for Statistical SAS programming.
13. Stay informed on new SAS developments relevant to clinical trial data management and update the Direct Manager.
14. Ensure KPI and metrics for assigned studies are met.
15. Complete required trainings on time.
16. Ensure daily completion of TRACK system, with correct entry of billable and non-billable time.
17. Perform other tasks as assigned.

• Scientific degree.
• At least 1 year of experience in CRO, biotech, pharma, research institutes in a similar role (preferred).
• Knowledge of HA requirements pertaining to pharmaceutical research and SAS programming.
• Knowledge in statistics and its applications to clinical trials.
• Knowledge of SAS and CDISC standards (SDTM, ADaM).
• Fluent in English.
• Planning and organizational skills.
• Communication skills.
• Team-working orientation.

We offer a competitive salary, bonuses, and other benefits, along with opportunities for professional development within an expanding international company. Please review the personal data processing notice on our website.

OPIS is an international CRO with 25 years of experience in conducting Phase I-IV, non-interventional, and medical device studies worldwide. We provide state-of-the-art IT solutions and innovative approaches to complex projects. Our expertise spans all phases of drug-related trials and medical device investigations, with global locations offering comprehensive clinical research services.