Junior Statistical SAS Programmer

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

Descrizione del lavoro

A leading international CRO seeks a Junior Statistical SAS Programmer to develop SAS programs for clinical trials, working closely with Biostatistics and Data Management staff. The role requires knowledge of SAS, statistical applications, and CDISC standards. The company offers a competitive salary, bonuses, and professional development opportunities within an expanding organization.

Servizi

Competitive salary

Bonuses

Opportunities for professional development

Competenze

• At least 1 year of experience in a similar role.
• Knowledge of HA requirements for pharmaceutical research.
• Familiarity with SDTM and ADaM datasets.

Mansioni

• Develop SAS programs for clinical trials datasets and documentation.
• Validate ADaM datasets and ensure compliance with CDISC standards.
• Collaborate with Biostatistics and Data Management staff on projects.

Conoscenze

SAS programming

Knowledge of statistics

Planning and organizational skills

Team-oriented attitude

Strumenti

CDISC standards

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 and develop SAS programs to import/reconcile this data
• Develop and validate SAS programs to identify Non-Protocol Deviations
• Collaborate with Biostatistics and Data Management staff on clinical trials/projects
• Maintain and archive SAS programming documentation
• Establish and maintain SOPs and templates related to Statistical SAS programming
• Ensure awareness of new SAS developments relevant to clinical trial data management and update the Direct Manager
• Meet KPIs and metrics for assigned studies
• Complete required trainings by the due date
• Accurately complete daily entries 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 (preferred)
• Knowledge of HA requirements related to pharmaceutical research and SAS programming
• Knowledge of statistics and its applications to clinical trials
• Knowledge of SAS and CDISC standards (SDTM, ADaM)
• Planning and organizational skills
• Team-oriented attitude

What we offer :

We offer a competitive salary, bonuses, and other 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 worldwide. We provide state-of-the-art technology solutions and innovative approaches to complex projects.

Our expertise spans all phases of drug-related trials, supporting sponsors beyond therapeutic areas, including 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.