SAS Data Programmer

OPIS; Chieti; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A leading international CRO, OPIS, seeks a Junior Statistical SAS Programmer to develop SAS programs for clinical trials and collaborate on data management. The ideal candidate should have a minimum of one year of experience in similar roles and knowledge of SAS and CDISC standards.

Competenze

• Minimum 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.
• Knowledge of SAS and CDISC standards (SDTM, ADaM).

Mansioni

• Develop SAS programs for generating datasets, tables, figures, and listings for clinical trials.
• Prepare and maintain CDISC documentation for ADaM.
• Contribute to developing standard SAS macros.

Conoscenze

Planning and organizational skills

Knowledge of HA requirements

SAS Programming

CDISC standards

Descrizione del lavoro

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. Write Programming Specifications of analysis datasets.
3. Prepare, maintain, and archive CDISC documentation for ADaM (Define.xml and ADRG).
4. Contribute to developing standard SAS macros and prepare the corresponding validation documents.
5. Liaise with Data Management team and develop SAS programs/macros/utilities to detect discrepancies in data.
6. Check requirements to handle external clinical data and develop SAS programs to import/reconcile external clinical data.
7. Develop and validate SAS programs for identification of Non-Protocol Deviations.
8. Collaborate with Biostatistics and Data Management staff on clinical trials/projects.
9. Prepare, maintain, and archive SAS programming documentation.
10. Assist in establishing and maintaining SOPs and related templates for Statistical SAS programming.
11. Stay informed on new SAS developments relevant to clinical trial data management and update the Direct Manager accordingly.
12. Complete all required trainings on time, including study trainings, OPIS and Sponsor SOPs, and others as assigned.
13. Minimum 1 year of experience in CRO, biotech, pharma, or research institutes in a similar role is preferred.
14. Knowledge of HA requirements related to pharmaceutical research and SAS programming.
15. Knowledge of SAS and CDISC standards (SDTM, ADaM).
16. Planning and organizational skills.

Please read the information notice on the processing of personal data in the candidates’ information section of our company website.

OPIS is an international CRO with 25 years of experience in conducting Phase I-IV, non-interventional, and medical device studies worldwide. We offer state-of-the-art technology solutions and innovative approaches to complex projects.

Our expertise covers all phases of drug-related trials, providing comprehensive services including scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture, quality assurance, and training.