Junior Statistical SAS Programmer

Opis S.r.l.; Varese; In loco; EUR 30.000 - 40.000; Tempo pieno

Descrizione del lavoro

Un'azienda internazionale nel settore della ricerca clinica cerca un Junior Statistical SAS Programmer per sviluppare e convalidare programmi SAS per studi clinici. Richiesta esperienza nel settore farmacologico e conoscenze dei requisiti CDISC. Offriamo un salario competitivo e opportunità di sviluppo professionale in un ambiente internazionale in espansione.

Servizi

Salario competitivo

Bonus

Sviluppo professionale

Competenze

• Almeno un anno di esperienza in CRO, biotech, pharma o istituti di ricerca in un ruolo simile.
• Conoscenza dei requisiti HA relativi alla ricerca farmaceutica e alla programmazione SAS.
• Conoscenza delle statistiche e delle sue applicazioni nelle sperimentazioni cliniche.

Mansioni

• Sviluppare programmi SAS per la generazione di dataset e report per studi clinici.
• Collaborare con il personale di Biostatistica e Data Management su progetti clinici.
• Convalidare i dataset ADaM utilizzando Pinnacle 21.

Conoscenze

Programmazione SAS

CDISC standards

Statistiche

Pianificazione

Lavoro di squadra

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.

Key responsibilities include:

• Develop SAS programs for generating datasets, tables, figures, and listings for clinical trials, publications, and 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 for data discrepancy detection.
• Handle external clinical data requirements and develop programs to import/reconcile such 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.
• Help establish and maintain SOPs, templates, and standards related to SAS programming.
• Stay informed on new SAS developments relevant to clinical data management and update the Direct Manager.
• Ensure KPIs and metrics for assigned studies are met.
• Complete required trainings on time.
• Accurately complete daily entries in the TRACK system.
• Perform other assigned tasks.

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.
• Knowledge of statistics and its applications in clinical trials.
• Proficiency in SAS and CDISC standards (SDTM, ADaM).
• Strong planning and organizational skills.
• Team-oriented mindset.

What we offer:

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

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Who we are:

OPIS is an international CRO with 25 years of experience in Phase I-IV, non-interventional, and medical device studies worldwide. We provide state-of-the-art technological solutions and innovative approaches to complex projects.

Our expertise covers all phases of drug trials, supporting sponsors across therapeutic areas, including medical and diagnostic 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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