Graduate Programmer

OPIS; Arezzo; In loco; EUR 28.000 - 40.000; Tempo pieno

Descrizione del lavoro

A global CRO with 25 years of experience is seeking a Junior Statistical SAS Programmer to develop SAS programs for clinical studies. The role involves collaborating with Biostatistics and Data Management teams, ensuring adherence to ICH E3 guidelines, and requires proficiency in SAS and CDISC standards.

Competenze

• At least 1 year of experience in a similar role is preferred.
• Proficiency in SAS and CDISC standards (SDTM, ADaM).

Mansioni

• Developing SAS programs for datasets, tables, figures, and listings for clinical trials.
• Writing programming specifications for analysis datasets.
• Collaborating with Biostatistics and Data Management teams.

Conoscenze

SAS

CDISC standards

Planning skills

Organizational skills

Descrizione del lavoro

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.

Key responsibilities include:

1. Developing SAS programs for datasets, tables, figures, and listings for clinical trials, publications, and Health Authorities requests.
2. Writing programming specifications for analysis datasets.
3. Preparing, maintaining, and archiving CDISC documentation for ADaM (Define.xml and ADRG).
4. Contributing to the development of standard SAS macros and validation documents.
5. Liaising with Data Management to develop SAS programs, macros, and utilities to detect data discrepancies.
6. Handling external clinical data by developing SAS programs for import and reconciliation.
7. Developing and validating SAS programs for identifying Non-Protocol Deviations.
8. Collaborating with Biostatistics and Data Management teams on projects.
9. Preparing, maintaining, and archiving SAS programming documentation.
10. Assisting in establishing and maintaining SOPs and related templates for Statistical SAS programming.
11. Staying informed on new SAS developments relevant to clinical trial data management and updating the Direct Manager accordingly.
12. Completing required trainings on time, including study-specific, OPIS, and Sponsor SOPs.

Qualifications and Skills:

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. Proficiency in SAS and CDISC standards (SDTM, ADaM).
4. Strong planning and organizational skills.

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OPIS is a global CRO with 25 years of experience in Phase I-IV, non-interventional, and medical device studies. We provide state-of-the-art IT solutions and innovative approaches to complex projects, covering all phases of drug-related trials and offering comprehensive clinical research services worldwide.