Junior Statistical SAS Programmer

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

Descrizione del lavoro

A leading international CRO is seeking a Junior Statistical SAS Programmer responsible for developing SAS programs for clinical studies. The role involves collaboration with various teams, utilizing CDISC standards, and contributing to documentation efforts. Competitive salary and benefits offered for successful candidates.

Servizi

Competitive salary

Bonuses

Benefits

Opportunities for professional growth

Competenze

• Minimum of 1 year experience in CRO, biotech, or pharma.
• Preferred knowledge of HA requirements for pharmaceutical research.
• Proficiency in SAS and CDISC standards (SDTM, ADaM).

Mansioni

• Develop SAS programs for clinical datasets, tables, and listings.
• Collaborate with Biostatistics and Data Management teams.
• Prepare and maintain CDISC documentation like Define.xml and ADRG.

Conoscenze

Knowledge of HA requirements

Understanding of statistics

Proficiency in SAS

Knowledge of CDISC standards

Strong planning and organizational skills

Team-oriented attitude

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:

• Developing SAS programs for datasets, tables, figures, and listings for clinical trials, publications, and health authority requests.
• Using CDISC guidelines to generate SDTM and ADaM datasets.
• Writing programming specifications for analysis datasets.
• Validating ADaM datasets with Pinnacle 21.
• Preparing and maintaining CDISC documentation such as Define.xml and ADRG.
• Developing standard SAS macros and validation documents.
• Liaising with Data Management to develop programs and macros for data discrepancy detection.
• Handling external clinical data import and reconciliation through SAS programs.
• Developing and validating programs for identifying Non-Protocol Deviations.
• Collaborating with Biostatistics and Data Management teams.
• Maintaining SAS programming documentation.
• Assisting in establishing and maintaining SOPs, templates, and programming standards.
• Staying informed on new SAS developments relevant to clinical data management.
• Ensuring KPIs and metrics are met.
• Completing required trainings on time.
• Accurately entering data into the TRACK system daily.
• Performing 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 attitude.

What We Offer:

Competitive salary, bonuses, benefits, and opportunities for professional growth within an expanding international company.

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About Us:

OPIS is a 25-year-old international CRO specializing in Phase I-IV, non-interventional, and medical device studies. We leverage state-of-the-art technology and innovative approaches to handle complex projects globally, offering comprehensive clinical research services.