6 дней назад
Senior Principal Statistical Programmer (SAS)
152 000 - 190 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Principal Statistical Programmer (SAS): Designing, validating, and maintaining statistical programming deliverables for clinical trials from Phase I through regulatory submission with an accent on SAS, CDISC standards, and FDA/EMA compliance. Focus on generating SDTM, ADaM, and TLFs, supporting regulatory submissions, mentoring programmers, and bridging clinical programming with AI infrastructure.
Location: Remote - US
Salary: $152K–$190K annually
Company
is a clinical-stage life-science and technology company developing medicines through an AI-driven drug discovery and development platform.
What you will do
- Lead the design, development, validation, and maintenance of SAS programs generating SDTM, ADaM, and tables, listings, and figures.
- Ensure compliance with CDISC standards, FDA and EMA guidance, and internal SOPs.
- Collaborate with biostatistics, data management, and clinical operations teams to define programming requirements and timelines.
- Perform quality control and peer reviews while serving as a technical subject matter expert and mentoring junior programmers.
- Support clinical study reports, regulatory submission packages, and responses to regulatory agencies.
- Provide technical leadership for vendor oversight and outsourced programming activities.
Requirements
- Bachelor’s or master’s degree in computer science, statistics, mathematics, life sciences, or a related field.
- At least 10 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry.
- Strong proficiency in SAS/Base, SAS/Macro, SAS/SQL, and SAS/Graph.
- Strong experience with CDISC SDTM and ADaM, plus familiarity with define.xml and Pinnacle 21.
- Experience supporting FDA and/or EMA regulatory submissions.
- Must be based in the United States for this remote role.
Nice to have
- Oncology experience.
- Python familiarity.
- Experience with cloud-based data systems or programming in a validated GxP environment.
Culture & Benefits
- Inclusive environment focused on collaboration across diverse backgrounds and experiences.
- Company-paid healthcare and flexible spending accounts.
- Voluntary life insurance and 401(k) matching.
- Uncapped vacation.
- Access to a San Diego facility with an onsite gym and dining.
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