Role Summary
A clinical-stage biotech focused on precision oncology is looking to bring on a Senior Manager of Statistical Programming to support a growing development pipeline and lead programming activities across key clinical studies.
Responsibilities:
- Collaborate closely with cross-functional stakeholders to define programming strategies and timelines.
- Lead statistical programming for assigned clinical trials
- Develop and validate SDTM and ADaM datasets, as well as TLFs in line with industry standards and internal programming conventions.
- Provide technical leadership on study-level programming activities and ensure outputs meet regulatory expectations.
- Support development and maintenance of programming SOPs and internal standards.
- Contribute to preparation of submission-ready deliverables for global health authorities.
- Develop and maintain reusable programming tools, macros, and templates to support efficient data processing and analysis.
- Review key study documentation and contribute programming input to ensure efficient downstream analyses.
Requirements:
- Degree in Statistics, Computer Science, Life Sciences, or a related field.
- 5+ years of industry statistical programming experience
- Familiarity with industry data standards and regulatory submission expectations.
- Experience collaborating within cross-functional clinical development teams.
- Exposure to additional programming languages such as R considered beneficial.
- Strong attention to detail and the ability to manage multiple priorities in a fast-moving environment.
Compensation DOE - $150k - $220k salary + bonus, equity and supporting package