lavori da Farmacovigilanza in località United States

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.

Some of what you'll do :

Develop SAS programs for generating datasets, tables, figures and listings for clinical trials (according to ICH E3) and / or publication, and / 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 the corresponding validation documents Liaise with Data Management team and develop SAS programs / macros and utilities to detect discrepancies in the data Check the requirements to handle external clinical data and develop the 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 Prepare, maintain and archive SAS programming documentation Collaborate in establishing and maintaining standard operating procedures (SOPs) and corresponding forms / templates related to Statistical SAS programming Collaborate in establishing and maintaining document / programming standards Keep informed on new SAS developments relevant to the clinical trial data management promptly updating the Direct Manager Ensure that KPI and metrics for the assigned studies are met Perform and complete on time all required trainings (study trainings, training on OPIS and / or Sponsor SOPs, all other applicable trainings) by the assigned due date Ensure daily completion of TRACK system, correct entry of appropriate billable and non-billable time Perform other tasks as assigned

What we're looking for :

Scientific degree At least 1 year of experience in CRO, biotech, pharma, research institutes in similar role is preferred Knowledge of HA requirements pertaining to pharmaceutical research and specifically to SAS programming Knowledge in statistics and its applications to clinical trials Knowledge of SAS and CDISC standards (SDTM, ADaM) Fluent in English Planning and organizational skills Communication skills Team-working oriented

What we offer :

We offer a competitive salary, bonuses, and other benefits together with the opportunity to develop your professional career with an expanding and growing international company. Please read the information notice on the processing of personal data in the candidates’ information section of our company website.

Who we are :

OPIS is an International CRO with 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects. OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.