Junior Statistical SAS Programmer

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

Descrizione del lavoro

OPIS is seeking a Junior Statistical SAS Programmer to develop SAS programs for clinical studies, following ICH E3 guidelines. The ideal candidate will have experience in CRO, proficiency in SAS, and knowledge of CDISC standards. This role offers opportunities for professional development within an expanding international company.

Servizi

Competitive salary

Bonuses

Benefits

Opportunities for professional development

Competenze

• At least 1 year of experience in a similar role in CRO, biotech, pharma, or research.
• Proficiency in SAS and knowledge of CDISC standards (SDTM, ADaM).

Mansioni

• Develop SAS programs for datasets, tables, figures, and listings for clinical trials.
• Validate ADaM datasets and prepare CDISC documentation.
• Collaborate with Biostatistics and Data Management staff.

Conoscenze

SAS

CDISC standards

Statistics

Planning

Organizational skills

Team-oriented attitude

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 :

• Develop SAS programs for generating datasets, tables, figures, and listings for clinical trials (according to ICH E3), publications, or Health Authorities requests
• Use CDISC guidelines to generate SDTM / ADaM datasets
• Write Programming Specifications of analysis datasets
• Validate ADaM datasets using Pinnacle 21
• Prepare, maintain, and archive CDISC documentation for ADaM (Define.xml and ADRG)
• Contribute to developing standard SAS macros and prepare validation documents
• Liaise with Data Management team to develop SAS programs/macros/utilities to detect data discrepancies
• Handle external clinical data: develop SAS programs to import/reconcile data
• Develop and validate SAS programs for identifying Non-Protocol Deviations
• Collaborate with Biostatistics and Data Management staff on clinical trials/projects
• Maintain and archive SAS programming documentation
• Establish and maintain SOPs and related templates for Statistical SAS programming
• Maintain document/programming standards
• Stay informed on new SAS developments relevant to clinical trial data management and update the Direct Manager
• Ensure KPIs and metrics for assigned studies are met
• Complete required trainings on time
• Accurately record time in the TRACK system daily
• Perform other assigned tasks

What we're looking for :

• At least 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 is desirable.
• Knowledge in statistics and its applications to clinical trials
• Proficiency in SAS and CDISC standards (SDTM, ADaM)
• Planning and organizational skills
• Team-oriented attitude

What we offer :

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

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

Who we are :

OPIS is an international CRO with 25 years of experience in Phase I-IV, non-interventional, and medical device studies globally. We provide cutting-edge IT solutions and innovative approaches to complex projects.

Our expertise spans all phases of drug-related trials, supporting sponsors across therapeutic areas, including medical and diagnostic devices. With global locations, we offer comprehensive clinical research services, including scientific advice, medical writing, trial start-up, monitoring, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture, quality assurance, and training.