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). The role collaborates with Biostatistics and Data Management staff on clinical trials/projects. Responsibilities: 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 for data discrepancy detection. Handle external clinical data requirements and develop programs for import/reconciliation. Develop and validate SAS programs for identifying Non-Protocol Deviations. Collaborate on clinical trials/projects with Biostatistics and Data Management staff. Maintain SAS programming documentation. Establish and maintain SOPs, templates, and programming standards. Stay informed on new SAS developments relevant to clinical trial data management. Ensure KPIs and metrics are met for assigned studies. Complete required trainings timely. Accurately record daily time in the TRACK system. Perform other tasks as assigned. Qualifications: Scientific degree. At least 1 year of experience in CRO, biotech, pharma, or research institutes in a similar role (preferred). Knowledge of HA requirements pertaining to pharmaceutical research and SAS programming. Knowledge in statistics and its applications to clinical trials. Proficiency in SAS and CDISC standards (SDTM, ADaM). Fluent in English. Strong planning, organizational, and communication skills. Team-oriented mindset. What We Offer: A competitive salary, bonuses, and benefits, along with professional development opportunities 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 provide state-of-the-art IT solutions and innovative approaches to complex projects, covering all phases of drug-related trials and medical investigations. J-18808-Ljbffr

Location: marche, IT

Posted Date: 5/12/2025