3 дня назад
Senior Statistical Programmer/Analyst Consultant (Cardiovascular, Renal)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Statistical Programmer/Analyst Consultant (Cardiovascular, Renal) (SAS/CDISC): Developing, validating, and maintaining SAS programs, SDTM and ADaM datasets, and TLFs for clinical studies with an accent on cardiovascular, renal, metabolism, and respiratory/immunology therapeutic-area programming. Focus on supporting regulatory submissions, collaborating with biostatistics and clinical teams, and delivering high-quality programming within project timelines.
Location: United States; remote role
Company
is a global full-service contract research organization providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
What you will do
- Develop, validate, and maintain SAS programs for clinical study data analysis and reporting.
- Create SDTM and ADaM datasets, tables, listings, and figures according to study requirements.
- Collaborate with biostatistics, data management, and clinical teams.
- Ensure programming deliverables meet quality standards and project timelines.
- Participate in study planning, review specifications, and support regulatory submission activities.
Requirements
- Strong SAS programming experience in the pharmaceutical or CRO industry.
- Hands-on experience supporting cardiovascular, renal, and metabolism studies, plus respiratory or immunology therapeutic-area experience.
- Experience generating and validating SDTM, ADaM, and TLFs, with a solid understanding of CDISC standards.
- Bachelor’s degree in computer science, statistics, or a related scientific discipline with 5 years of clinical programming experience, or a master’s degree with 6 years of experience.
- Working knowledge of ICH, Good Clinical Practice, clinical research, clinical trial processes, and regulatory terminology.
- Ability to work independently, manage multiple priorities, communicate effectively, and manage stakeholders.
Nice to have
- Experience supporting regulatory submissions.
Culture & Benefits
- Work directly with a single sponsor while receiving the career opportunities and security of a global CRO.
- Access to continuous professional training and development.
- Supportive, quality-focused, and inclusive work environment.
- Opportunity to work with professionals across the Americas, Europe, and Asia-Pacific.
Hiring process
- CV submission is followed by an application acknowledgement.
- Qualified candidates are invited to a phone interview as the first step.
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