Requirements: English
Company: OPIS
Region: Varese , Lombardy
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.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 and develop SAS programs/macros/utilities to detect discrepancies in data.Develop SAS programs to import/reconcile external clinical data.Develop and validate SAS programs for identification of Non-Protocol Deviations.Collaborate with Biostatistics and Data Management staff on clinical trials/projects.Maintain SAS programming documentation.Establish and maintain SOPs and related templates for SAS programming.Stay informed on new SAS developments relevant to clinical trial data management.Ensure KPI and metrics are met for assigned studies.Complete required trainings on time.Accurately maintain daily entries in the TRACK system.Perform other assigned tasks.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 of statistics and its applications 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:A competitive salary, bonuses, and benefits, with opportunities for professional growth within an expanding international company.Please review the personal data processing notice on our website.About Us:OPIS is an international CRO with 25 years of experience 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 offering comprehensive clinical research services globally.#J-18808-Ljbffr