Requirements: English
Company: OPIS
Region: Pordenone , Friuli-Venezia Giulia
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:Develop SAS programs for generating datasets, tables, figures, and listings for clinical trials, publications, and Health Authorities requests.Utilize CDISC guidelines to create SDTM and ADaM datasets.Write programming specifications for analysis datasets.Validate ADaM datasets using Pinnacle 21.Maintain and archive CDISC documentation such as Define.xml and ADRG.Contribute to the development of standard SAS macros and validation documents.Liaise with Data Management to develop SAS programs and macros to detect data discrepancies.Develop SAS programs for importing and reconciling external clinical data.Create and validate SAS programs for identifying Non-Protocol Deviations.Collaborate with teams on clinical trial documentation and SOPs related to SAS programming.Stay informed on new SAS developments relevant to clinical data management.Ensure KPIs and study metrics are met and complete all required trainings on time.Maintain accurate daily entries in the TRACK system.Perform other assigned tasks as needed.Qualifications:Scientific degree.At least 1 year of experience in CRO, biotech, pharma, or research institutes (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).Fluency in English.Strong planning, organizational, and communication skills.Team-oriented mindset.What We Offer:Competitive salary, bonuses, and benefits, along with opportunities for professional development within an expanding international company.About Us:OPIS is a global CRO with 25 years of experience in conducting a wide range of clinical trials and offering innovative technology solutions. We provide comprehensive services across all phases of drug development and medical device studies worldwide.#J-18808-Ljbffr