10 дней назад
Senior Statistical Programmer (SAS)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Statistical Programmer (SAS) (Clinical Research): Generating tables, listings, and graphs from clinical trial databases and preparing statistical programming deliverables for regulatory submissions with an accent on SAS programming, SDTM and ADaM standards, and clinical data compliance. Focus on developing specifications, pooling datasets, producing BIMO outputs and define.xml documentation, and leading study or small programming project teams.
Location: Remote within Brazil; the posting lists São Paulo, Brazil.
Company
is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submission expertise.
What you will do
- Generate tables, listings, and graphs from clinical trial databases using SAS.
- Develop programming deliverables according to the System Development Life Cycle.
- Prepare SDTM and ADaM specifications and support regulatory submission activities.
- Produce pooled datasets, BIMO outputs, define.xml files, Reviewer's Guides, and SDSP documentation.
- Lead study teams or small statistical programming projects.
Requirements
- Master’s degree required for statistical roles.
- At least 5 years of experience in statistical programming or a similar field.
- Advanced SAS programming skills, including SAS Base and SAS Macros.
- Advanced knowledge of SDTM, ADaM, e-submission standards, guidelines, and regulations.
- Knowledge of ICH, 21 CFR Part 11, FDA, GCP, ISO 9001, and ISO 27001 requirements.
- Strong scientific knowledge, problem-solving ability, organization, communication, and collaboration skills.
Nice to have
- Hands-on experience with clinical trials and pharmaceutical development.
- Familiarity with CROs, scientific and clinical terminology, and the drug development process.
Culture & Benefits
- Full-time employment with remote work from within Brazil.
- Supportive, collaborative, and inclusive work environment.
- Opportunity to contribute to clinical research supporting pharmaceutical, biotech, and medical device industries.
- is a Great Place to Work certified organization with a global presence.
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