Junior Statistical SAS Programmer

JR Italy; Roma; In loco; EUR 30.000 - 60.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Junior Statistical SAS Programmer to join their dynamic team. In this role, you will develop SAS programs to generate datasets and reports for clinical studies, ensuring compliance with ICH E3 guidelines. You'll collaborate closely with Biostatistics and Data Management teams, contributing to the success of clinical trials. This exciting opportunity offers competitive salary and benefits within a growing international company dedicated to innovative clinical research solutions. If you're passionate about statistics and programming, this role is perfect for you.

Servizi

Competitive Salary

Bonuses

Professional Development Opportunities

Competenze

• 1+ year experience in CRO, biotech, or pharma is preferred.
• Proficiency in SAS and understanding of CDISC standards.

Mansioni

• Develop SAS programs for clinical trials and publications.
• Collaborate with Biostatistics and Data Management teams.
• Maintain SAS programming documentation and SOPs.

Conoscenze

SAS Programming

CDISC Standards (SDTM, ADaM)

Statistical Knowledge

Planning and Organizational Skills

Team Collaboration

Formazione

Bachelor's Degree in Statistics or Related Field

Strumenti

Pinnacle 21

Descrizione del lavoro

Job Title: Junior Statistical SAS Programmer

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.

Responsibilities:

1. Develop SAS programs for creating datasets, tables, figures, and listings for clinical trials, publications, and regulatory requests.
2. Utilize 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 such as Define.xml and ADRG.
6. Contribute to the development of standard SAS macros and validation documents.
7. Coordinate with Data Management to develop SAS programs/macros and utilities for data discrepancy detection.
8. Develop SAS programs to handle external clinical data import and reconciliation.
9. Create and validate SAS programs for identifying Non-Protocol Deviations.
10. Collaborate with Biostatistics and Data Management teams on clinical trials and projects.
11. Maintain SAS programming documentation.
12. Assist in establishing and maintaining SOPs and related documentation.
13. Stay informed on new SAS developments relevant to clinical data management.
14. Ensure KPIs and metrics for assigned studies are met.
15. Complete required training on time, including study-specific and SOP trainings.
16. Accurately record daily work hours in the TRACK system.
17. Perform additional tasks as assigned.

Qualifications:

• Minimum of 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 and SAS programming.
• Understanding of statistics and its application to clinical trials.
• Proficiency in SAS and familiarity with CDISC standards (SDTM, ADaM).
• Strong planning and organizational skills.
• Team-oriented mindset.

What We Offer:

Competitive salary, bonuses, and benefits, along with opportunities for professional development within a growing international company.

About Us:

OPIS is an international CRO with 25 years of experience in conducting clinical trials across various phases and medical devices. We leverage cutting-edge technology and innovative approaches to manage complex projects globally, providing comprehensive clinical research services.