Junior Statistical SAS Programmer

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Junior Statistical SAS Programmer, Sassari

Client : OPIS

Location : Sassari

Job Category : Other

EU work permit required :

Job Reference : 17999619097519718433710

Job Views : Posted :

02.05.2025

Expiry Date : 16.06.2025

Job Description :

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.

Some of what you'll do :

1. Develop SAS programs for generating datasets, tables, figures, and listings for clinical trials (according to ICH E3) and/or publication, and/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. Collaborate in establishing and maintaining SOPs and related templates for Statistical SAS programming.
13. Keep informed on new SAS developments relevant to clinical trial data management and update the Direct Manager accordingly.
14. Ensure that KPI and metrics for the assigned studies are met.
15. Perform and complete all required trainings by the due date.
16. Ensure daily completion of TRACK system entries, including billable and non-billable time.
17. Perform other tasks as assigned.

What we're looking for :

• At least 1 year of experience in CRO, biotech, pharma, or research institutes in a similar role is 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).
• Planning and organizational skills.
• Team-oriented attitude.

What we offer :

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

Please read the information notice on the processing of personal data on our company website.

Who we are :

OPIS is an international CRO with 25 years of experience in conducting Phase I-IV, non-interventional, and medical device studies worldwide. We provide advanced IT solutions and innovative approaches to complex projects, covering all phases of drug trials and offering comprehensive clinical research services globally.