Junior Statistical SAS Programmer

OPIS; Pescara; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

Join a growing international CRO as a Junior Statistical SAS Programmer. Responsible for developing SAS programs for clinical studies, you'll collaborate with data management and biostatistics teams. We offer competitive pay and development opportunities within a supportive environment.

Servizi

Competitive salary

Bonuses

Professional development opportunities

Competenze

• At least 1 year of experience in a similar role in CRO, biotech, or pharma.
• Knowledge of HA requirements and SAS programming.
• Familiarity with SDTM and ADaM datasets.

Mansioni

• Develop SAS programs for generating datasets, tables, figures.
• Collaborate with Biostatistics and Data Management teams.
• Prepare and maintain programming documentation and SOPs.

Conoscenze

Knowledge of SAS

Team-oriented mindset

Planning and organizational skills

Knowledge of CDISC standards

Knowledge of statistics

Descrizione del lavoro

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 publications, 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 data
• Check requirements to handle external clinical data and 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
• Prepare, maintain, and archive SAS programming documentation
• Collaborate in establishing and maintaining standard operating procedures (SOPs) and related forms/templates
• Collaborate in establishing and maintaining document/programming standards
• Keep informed on new SAS developments relevant to clinical trial data management and promptly update the Direct Manager
• Ensure that KPI and metrics for the assigned studies are met
• Perform and complete required trainings on time (study trainings, OPIS and Sponsor SOPs, etc.)
• Ensure daily completion of TRACK system, correct entry of billable and non-billable time
• Perform other tasks as assigned

What we're looking for :

• At least 1 year of experience in CRO, biotech, pharma, research institutes in a similar role is preferred. Knowledge of HA requirements pertaining to pharmaceutical research and SAS programming is a plus.
• Knowledge of statistics and its applications to clinical trials
• Knowledge of SAS and CDISC standards (SDTM, ADaM)
• Planning and organizational skills
• Team-oriented mindset

What we offer :

We offer a competitive salary, bonuses, and other benefits, along with opportunities for professional development within 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 device studies worldwide. We offer state-of-the-art information technology solutions and innovative approaches to meet the increasing complexity and variety of projects.

Our expertise spans all phases of drug-related trials, supporting sponsors beyond the therapeutic area, including clinical investigations for medical and diagnostic devices. With global locations, OPIS provides comprehensive clinical research services such as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture, quality assurance, and training.