Junior Statistical SAS Programmer

Opis S.r.l.; Prato; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A global CRO is seeking a Junior Statistical SAS Programmer in Tuscany, Italy. You will develop SAS programs for clinical studies and ensure adherence to CDISC standards. The ideal candidate has experience in CRO or pharma settings, strong SAS proficiency, and a team-oriented attitude. Competitive salary and benefits are offered.

Servizi

Competitive salary

Bonuses

Professional development opportunities

Competenze

• At least 1 year of experience in a similar role is preferred.
• Knowledge of HA requirements related to pharmaceutical research and SAS programming.
• Understanding of statistics and its application to clinical trials.

Mansioni

• Develop SAS programs for datasets, tables, figures, and clinical trials.
• Use CDISC guidelines to generate SDTM / ADaM datasets.
• Write programming specifications for analysis datasets.

Conoscenze

Proficiency in SAS

Knowledge of CDISC standards

Understanding of statistics

Planning and organizational skills

Team-oriented attitude

Descrizione del lavoro

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. The role involves collaboration with Biostatistics and Data Management staff on clinical trials and projects.

Responsibilities include:

• Developing SAS programs for datasets, tables, figures, and listings for clinical trials, publications, and Health Authorities requests.
• Using CDISC guidelines to generate SDTM / ADaM datasets.
• Writing programming specifications for analysis datasets.
• Validating ADaM datasets using Pinnacle 21.
• Preparing, maintaining, and archiving CDISC documentation for ADaM (Define.xml and ADRG).
• Developing standard SAS macros and validation documents.
• Liaising with Data Management to develop SAS programs, macros, and utilities to detect data discrepancies.
• Handling external clinical data and developing SAS programs for data import and reconciliation.
• Developing and validating SAS programs for identifying Non-Protocol Deviations.
• Collaborating with Biostatistics and Data Management teams on clinical projects.
• Maintaining SAS programming documentation.
• Establishing and maintaining SOPs, forms, and templates related to SAS programming.
• Staying informed on new SAS developments relevant to clinical data management.
• Ensuring KPIs and metrics are met for assigned studies.
• Completing required trainings on time.
• Accurately entering data into the TRACK system daily.
• Performing additional tasks as assigned.

Qualifications:

• 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.
• Understanding of statistics and its application to clinical trials.
• Proficiency in SAS and CDISC standards (SDTM, ADaM).
• Strong planning and organizational skills.
• Team-oriented attitude.

What we offer:

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

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Who we are:

OPIS is a global CRO with 25 years of experience in conducting Phase I-IV studies, non-interventional, and medical device trials worldwide. We provide state-of-the-art technology and innovative solutions for complex projects, covering all phases of drug-related trials and medical device investigations.

With global locations, we offer comprehensive clinical research services, including scientific advice, medical writing, trial start-up, monitoring, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture, quality assurance, and training.

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