Junior Statistical SAS Programmer

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

Descrizione del lavoro

A leading international CRO is seeking a Junior Statistical SAS Programmer to develop SAS programs for clinical studies, ensuring compliance with relevant guidelines and standards. The role includes key responsibilities such as writing programming specifications and validating datasets, ideally suited for someone with experience in CRO or similar environments. This is an excellent opportunity for professional development within a dynamic, expanding company, offering competitive compensation and benefits.

Servizi

Competitive salary

Bonuses

Professional development opportunities

Competenze

• At least 1 year of experience in CRO, biotech, pharma, or similar role preferred.
• Knowledge of HA requirements and SAS programming.
• Proficiency in SAS and familiarity with CDISC standards.

Mansioni

• Developing SAS programs for datasets, tables, figures, and listings for clinical studies.
• Validating datasets using Pinnacle 21 and generating SDTM and ADaM datasets.
• Collaborating with Biostatistics and Data Management teams.

Conoscenze

SAS

Statistics

Organizational skills

Teamwork

Descrizione del lavoro

The Junior Statistical SAS Programmer, under the supervision of the Direct Manager, is primarily involved in developing SAS programs for generating 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.

Key responsibilities include:

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

Qualifications and skills:

• 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 familiarity with CDISC standards (SDTM, ADaM).
• Strong planning and organizational skills.
• Team-oriented mindset.

What we offer:

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

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About us:

OPIS is an international CRO with 25 years of experience conducting a wide range of clinical studies globally, offering cutting-edge technology and innovative solutions across all phases of drug trials, including medical devices. We provide comprehensive services from scientific advice to data management and pharmacovigilance, supported by global clinical research locations worldwide.

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