22 часа назад
Senior Manager, Statistical Programming (SAS)
153 935 - 199 210$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, Statistical Programming (SAS): Leading the production of clinical-trial analysis datasets, tables, listings, and statistical outputs for study reports and regulatory submissions with an accent on clinical programming standards, CDISC requirements, and oncology and cell-therapy studies. Focus on managing programming resources, supervising programmers, resolving study issues, and ensuring high-quality deliverables for regulatory and scientific objectives.
Location: United States – Remote
Salary: $153,935–$199,210 per year, plus potential annual bonus, stock-based incentives, paid time off, and benefits.
Company
, a Gilead company, is a biopharmaceutical company developing CAR T-cell and T-cell receptor therapies for cancer treatment.
What you will do
- Lead statistical programming activities for therapeutic projects and support clinical study deliverables and timelines.
- Generate or oversee analysis datasets, tables, listings, and statistical outputs for study reports and integrated summaries.
- Collaborate with Clinical Development, Biometrics, Clinical Data Science, Regulatory Affairs, external vendors, and other cross-functional groups.
- Plan programming resource needs, allocate capacity, and manage a small team of employees and contractors.
- Design and code analysis files, maintain documentation, and ensure compliance with departmental procedures and regulatory requirements.
- Resolve study issues, negotiate timelines, support strategic initiatives, and provide training and technical guidance.
Requirements
- 8 years of experience with a BS degree in Biostatistics, Computer Science, or an equivalent field; alternatively, 6 years with an MS degree or a PhD with no experience requirement.
- Experience with clinical and statistical programming processes, clinical trial design, reporting, and regulatory submissions.
- Extensive experience using SAS, including developing and using SAS macros.
- Advanced knowledge of CDISC standards, including CDASH, SDTM, and ADaM, as well as GCP and ICH requirements.
- Experience leading programming activities, supervising personnel, managing resources, and resolving project issues.
- Strong communication, interpersonal, analytical, problem-solving, and negotiation skills.
Nice to have
- Advanced degree in Biostatistics, Computer Science, or an equivalent field.
- 8 or more years of pharmaceutical or CRO experience.
- Experience in oncology, hematology, or cell therapy.
- Experience with pivotal studies and NDA, BLA, or MAA regulatory submissions.
Culture & Benefits
- Remote work arrangement for the United States.
- Medical, dental, vision, and life insurance plans for eligible employees.
- Paid time off and potential discretionary annual bonus and stock-based long-term incentives.
- People leadership focused on inclusion, talent development, team empowerment, and employee growth.
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