Junior Statistical SAS Programmer

JR Italy; Como; 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 for clinical studies, ensuring compliance with ICH E3 guidelines and CDISC standards. You will collaborate closely with Biostatistics and Data Management teams, contributing to the development of datasets and documentation. This position offers competitive salary and benefits, along with opportunities for professional growth in a supportive and innovative environment. If you are passionate about statistics and programming, this is the perfect opportunity for you.

Servizi

Competitive salary

Bonuses

Professional growth opportunities

Competenze

• 1+ year experience in CRO, biotech, or pharma preferred.
• Proficiency in SAS and CDISC standards (SDTM, ADaM).

Mansioni

• Develop SAS programs for datasets and tables per ICH E3 guidelines.
• Collaborate with Biostatistics and Data Management teams.

Conoscenze

SAS Programming

CDISC Standards

Statistical Knowledge

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, publications, or Health Authorities requests. This role involves collaboration with Biostatistics and Data Management teams on clinical trials and projects.

Key Responsibilities:

1. Develop SAS programs for datasets, tables, figures, and listings in line with ICH E3 guidelines, publications, and Health Authorities requests.
2. Utilize CDISC standards to generate SDTM and ADaM datasets.
3. Write programming specifications for analysis datasets.
4. Validate ADaM datasets using Pinnacle 21.
5. Maintain and archive CDISC documentation, including Define.xml and ADRG files.
6. Contribute to the development of standard SAS macros and validation documents.
7. Coordinate with Data Management to develop programs and macros for data discrepancy detection.
8. Handle external clinical data, developing programs for data import and reconciliation.
9. Develop and validate SAS programs for identifying Non-Protocol Deviations.
10. Collaborate with Biostatistics and Data Management teams on clinical projects.
11. Maintain SAS programming documentation.
12. Assist in establishing and maintaining SOPs and related templates for statistical SAS programming.
13. Stay informed on new SAS developments relevant to clinical data management and update the team accordingly.
14. Ensure KPI and metrics for studies are achieved.
15. Complete required trainings on time, including study-specific, OPIS, and Sponsor SOPs.
16. Accurately update the daily TRACK system with billable and non-billable hours.
17. Perform additional tasks as assigned.

Qualifications:

• Minimum of 1 year 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 in clinical trials.
• Proficiency in SAS and 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 growth within an expanding international company.

Please review the personal data processing notice available on our company website.

About Us:

OPIS is an international CRO with 25 years of experience in conducting Phase I-IV, non-interventional, and medical device studies globally. We leverage advanced technology and innovative approaches to manage complex projects across various therapeutic areas, providing comprehensive clinical research services worldwide.