Junior Statistical SAS Programmer

OPIS; Novara; In loco; EUR 30.000 - 40.000; Tempo pieno

Descrizione del lavoro

OPIS, a leading international CRO, seeks a Junior Statistical SAS Programmer to develop SAS programs for clinical studies. The role involves validating datasets, collaborating with teams, and ensuring data integrity in compliance with regulatory standards. This position provides an opportunity to grow within an expanding global company.

Servizi

Competitive salary

Bonuses

Career development opportunities

Competenze

• At least 1 year of experience in CRO, biotech, pharma, or research.
• Proficiency in SAS and understanding of CDISC standards (SDTM, ADaM).
• Knowledge of HA requirements for pharmaceutical research.

Mansioni

• Develop SAS programs for generating datasets, tables, and listings for clinical trials.
• Validate ADaM datasets using Pinnacle 21.
• Collaborate with Biostatistics and Data Management staff on projects.

Conoscenze

SAS programming

CDISC standards

Statistics

Planning skills

Organizational skills

Teamwork

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.

Some of what you'll do :

1. Develop SAS programs for generating datasets, tables, figures, and listings for clinical trials (according to ICH E3), publications, and/or Health Authorities requests.
2. Use 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 prepare validation documents.
7. Liaise with Data Management team and develop SAS programs/macros/utilities to detect data discrepancies.
8. Handle external clinical data by developing SAS programs to import/reconcile data.
9. Develop and validate SAS programs for identifying Non-Protocol Deviations.
10. Collaborate with Biostatistics and Data Management staff on clinical trials/projects.
11. Prepare, maintain, and archive SAS programming documentation.
12. Assist in establishing and maintaining SOPs and related documentation standards.
13. Stay informed on new SAS developments relevant to clinical trial 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 time in the TRACK system daily.
17. Perform other tasks as assigned.

What we're looking for :

1. At least 1 year of experience in CRO, biotech, pharma, or research institutes in a similar role is preferred.
2. Knowledge of HA requirements related to pharmaceutical research and SAS programming.
3. Understanding of statistics and its applications to clinical trials.
4. Proficiency in SAS and CDISC standards (SDTM, ADaM).
5. Planning and organizational skills.
6. Team-oriented mindset.

What we offer :

We offer a competitive salary, bonuses, and other benefits, along with the opportunity to develop your professional career within an expanding international company.

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 leverage state-of-the-art technology and innovative approaches to manage complex projects across various therapeutic areas, supporting sponsors beyond clinical trials with comprehensive services including medical writing, trial management, data management, and more.