Junior Statistical Sas Programmer

The Junior Statistical SAS Programmer, under the supervision of the Direct Manager, is primarily responsible for developing SAS programs for generating datasets, tables, figures, and listings for clinical studies (according to ICH E3), publications, or Health Authorities requests. The role involves collaboration with Biostatistics and Data Management staff on clinical trials and projects. Responsibilities include: Developing SAS programs for datasets, tables, figures, and listings for clinical trials, publications, and Health Authorities requests. Using CDISC guidelines to generate SDTM and ADaM datasets. Writing Programming Specifications for analysis datasets. Validating ADaM datasets using Pinnacle 21. Preparing, maintaining, and archiving CDISC documentation for ADaM (Define.xml and ADRG). Contributing to the development of standard SAS macros and validation documents. Liaising with Data Management to develop SAS programs, macros, and utilities to detect data discrepancies. Handling external clinical data and developing SAS programs for import and reconciliation. Developing and validating SAS programs for identifying Non-Protocol Deviations. Collaborating with Biostatistics and Data Management teams on clinical trials and projects. Maintaining SAS programming documentation. Establishing and maintaining SOPs, templates, and programming standards. Staying informed on new SAS developments relevant to clinical trial data management and updating the Direct Manager accordingly. Ensuring KPIs and metrics are met for assigned studies. Completing required trainings on time. Accurately entering billable and non-billable time daily in the TRACK system. Performing additional tasks as assigned. Qualifications: 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. Understanding of statistics and its application to clinical trials. Proficiency in SAS and CDISC standards (SDTM, ADaM). Strong planning and organizational skills. Team-oriented mindset. What we offer: We provide a competitive salary, bonuses, and other benefits, along with opportunities for professional growth within an expanding international company. About us: OPIS is an international CRO with 25 years of experience in conducting Phase I-IV, non-interventional, and medical device studies worldwide. We offer advanced IT solutions and innovative approaches to complex projects, covering all phases of drug-related trials and medical device investigations, with global locations providing comprehensive clinical research services. J-18808-Ljbffr

Location: sardegna, IT

Posted Date: 6/26/2025