Junior Statistical SAS Programmer

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) and/or publication, and/or Health Authorities requests
• Use CDISC guidelines to generate SDTM/ADaM datasets
• Write Programming Specifications for 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 and develop SAS programs to import/reconcile such 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 documentation for Statistical SAS programming
• Keep 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 tasks as assigned

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 a plus.
• Understanding of statistics and its applications to clinical trials
• Knowledge of SAS and CDISC standards (SDTM, ADaM)
• Strong planning and organizational skills
• Team-oriented mindset

What we offer :

We offer a competitive salary, bonuses, and benefits, along with opportunities for professional development within an expanding international company.

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

Who we are :

OPIS is an international CRO with 25 years of experience conducting Phase I-IV, non-interventional, and medical device studies globally. We leverage state-of-the-art technology and innovative approaches to meet the increasing complexity of projects.

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