Principal / Associate Director, Statistical Programming

Responsibilities:
- Lead and contribute to statistical programming activities across multiple clinical studies and development programs.
- Develop, validate, review, and maintain SAS programs for data access, transformation, analysis, reporting, and regulatory submission activities.
- Review CRO deliverables including SDTM, ADaM, TLFs, Define.xml packages, and submission deliverables to ensure quality, accuracy, and adherence to company standards.
- Collaborate cross-functionally with Biostatistics, Clinical Data Management, Regulatory Operations, Medical Writing, Medical Affairs, and Clinical teams to ensure consistent and accurate use of clinical trial data.
- Support regulatory submissions (e.g., NDA/BLA activities, pooled analyses, ISS/ISE, and responses to regulatory agencies).
- Support programming standards, macros, automation tools, QC procedures, SOPs/working instructions, and submission processes.
- Participate in process improvement and automation initiatives, including evaluation of AI-enabled solutions.
- Coordinate with CRO partners to meet timelines, quality standards, and regulatory requirements.

Qualifications:
- Bachelor’s degree in Mathematics, Computer Science, Data Science, Statistics, or related life science field (Master’s preferred).
- 10+ years of relevant pharmaceutical/biotech experience with prior regulatory submission experience.
- Strong SAS programming experience (including SAS Macro development); R knowledge is a plus.
- Understanding of ICH and GCP; regulatory guidance and industry standards.
- In-depth CDISC knowledge (SDTM, ADaM) with extensive clinical trial implementation experience.
- Advanced statistical concepts; experience overseeing CRO programming deliverables.
- Preferred: NDA/BLA submission support, Define.xml, and submission validation.
- Strong communication, organization, problem-solving, and collaboration skills.

Application instructions:
- Submit via Madrigal Careers site on an ongoing basis.