22 часа назад
Manager, Statistical Programming (Oncology)
133 195 - 172 370$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, Statistical Programming (Oncology) (SAS/Clinical Trials): Leading statistical programming activities and producing analysis datasets, tables, listings, and statistical outputs for clinical study reports and regulatory submissions with an accent on oncology, cell therapy, CDISC standards, and regulatory compliance. Focus on overseeing concurrent therapeutic projects, resolving study-related issues, negotiating timelines, and ensuring high-quality programming deliverables using SAS.
Location: United States – Remote
Salary: $133,195–$172,370 per year, plus potential annual bonus, stock-based long-term incentives, paid time off, and benefits.
Company
is a biopharmaceutical company developing cancer immunotherapies, including CAR T-cell and TCR-engineered cell therapies.
What you will do
- Lead statistical programming activities for therapeutic projects and manage multiple concurrent projects.
- Generate or oversee analysis datasets, tables, listings, and statistical outputs for study reports and integrated summaries.
- Collaborate with Clinical Development, Clinical Data Science, Biometrics, Regulatory Affairs, and external vendors to deliver projects on time.
- Ensure programming and documentation follow departmental procedures and regulatory reporting requirements.
- Resolve study-related issues, negotiate timelines, and build stakeholder support.
- Represent the Programming group in Study Management Team meetings and contribute to process improvements and training recommendations.
Requirements
- Bachelor's degree with six years of experience, or master's degree with four years of experience.
- Six or more years of pharmaceutical or CRO experience.
- Extensive statistical programming experience with SAS, including SAS Macro development and use.
- Advanced knowledge of CDISC standards, including CDASH, SDTM, and ADaM.
- Thorough understanding of clinical trial design, reporting processes, GCP, ICH, and electronic regulatory submissions.
- Excellent communication, interpersonal, problem-solving, analytical, leadership, and conflict-resolution skills.
Nice to have
- Degree in Biostatistics, Computer Science, or an equivalent field.
- Experience in oncology, hematology, and cell therapy.
- Knowledge of long-term follow-up trials.
- Hands-on experience with pivotal studies and NDA, BLA, or MAA regulatory submissions.
Culture & Benefits
- Full-time employment with a remote position in 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.
- Inclusive workplace focused on employee development, empowerment, and diverse perspectives.
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