Junior Statistical SAS Programmer

OPIS; Terni; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading CRO is seeking a Junior Statistical SAS Programmer to develop SAS programs supporting clinical trials. The role involves close collaboration with Biostatistics and Data Management, ensuring data quality and adherence to regulatory guidelines. The candidate should have SAS programming skills and a background in pharmaceutical research.

Servizi

Competitive salary

Bonuses and benefits

Opportunities for professional development

Competenze

• At least 1 year of experience in a CRO, biotech, pharma, or research institutes.
• Knowledge of HA requirements related to pharmaceutical research.
• Proficiency in SAS and CDISC standards.

Mansioni

• Develop SAS programs for clinical trials and publications.
• Validate ADaM datasets using Pinnacle 21.
• Collaborate with Biostatistics and Data Management staff.

Conoscenze

SAS

CDISC standards

Statistics

Organizational skills

Teamwork

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), publications, or Health Authorities requests
• Use CDISC guidelines to generate SDTM / ADaM datasets
• Write programming specifications for 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 to develop SAS programs/macros/utilities to detect data discrepancies
• Handle external clinical data, developing SAS programs to import and reconcile data
• Develop and validate SAS programs for identifying Non-Protocol Deviations
• Collaborate with Biostatistics and Data Management staff on clinical trials/projects
• Maintain and archive SAS programming documentation
• Establish and maintain SOPs, templates, and standards related to SAS programming
• Stay informed on new SAS developments relevant to clinical data management
• Ensure KPI and metrics are met for assigned studies
• Complete required training on time
• Accurately record daily work hours in the TRACK system
• Perform other tasks as assigned

What we're looking for :

• At least 1 year of experience in CRO, biotech, pharma, or research institutes in a similar role is preferred
• Knowledge of HA requirements related to pharmaceutical research and SAS programming
• Knowledge 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 :

We offer a competitive salary, bonuses, and benefits, along with opportunities for professional development within an expanding international company.

Please review the personal data processing notice on our 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 globally. We provide cutting-edge IT solutions and innovative approaches to complex projects.

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