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 (according to ICH E3), publications, or Health Authorities requests. They collaborate with Biostatistics and Data Management staff on clinical trials and projects.Key Responsibilities include :Developing SAS programs for datasets, tables, figures, and listings for clinical trials, publications, and regulatory requests.Utilizing CDISC guidelines to generate SDTM and ADaM datasets.Writing specifications for analysis datasets.Validating ADaM datasets using Pinnacle 21.Preparing, maintaining, and archiving CDISC documentation such as Define.xml and ADRG.Developing standard SAS macros and validation documents.Liaising with Data Management to develop programs and macros to identify data discrepancies.Handling external clinical data import / reconciliation programs.Developing and validating SAS programs to identify Non-Protocol Deviations.Collaborating with Biostatistics and Data Management teams.Establishing and maintaining SOPs, templates, and programming standards.Keeping updated on SAS developments relevant to clinical data management.Ensuring KPIs and study metrics are met.Completing required training on time.Accurately entering data into the TRACK system daily.Performing additional tasks as assigned.Qualifications :Minimum 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 clinical trial applications.Proficiency in SAS and CDISC standards (SDTM, ADaM).Strong planning and organizational skills.Team-oriented mindset.What We Offer :Competitive salary, bonuses, benefits, and opportunities for professional development within an expanding international company.Please review the candidate data processing notice on our website.About Us :OPIS is a global CRO with 25 years of experience in clinical trials across phases I-IV, non-interventional studies, and medical devices. We leverage advanced technology and innovative approaches to manage complex projects worldwide, offering comprehensive clinical research services.I accept the Candidate Privacy Policy and authorize data processing as described.J-18808-LjbffrJ-18808-Ljbffr
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