Principal / Associate Director, Statistical Programming
Madrigal Pharmaceuticals
June 30, 2026
Remote friendly (Conshohocken, PA)
United States
Clinical Research and Development
Principal / Associate Director Statistical Programmer
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 for 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 including NDA/BLA activities, pooled analyses, ISS/ISE, and responses to regulatory agencies.
- Support development/maintenance of 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.
- Collaborate with CRO partners to ensure deliverables 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 degree preferred).
- 10+ years of relevant pharmaceutical/biotech experience, including prior regulatory submission experience.
- Strong SAS programming (including SAS Macro development); R programming a plus.
- Knowledge of regulatory guidance and industry standards (ICH, GCP).
- In-depth CDISC knowledge (SDTM, ADaM) with extensive clinical trial implementation experience.
- Advanced statistical concepts for clinical data analyses.
- Experience overseeing CRO-delivered programming.
- Preferred: NDA/BLA submission support, Define.xml, and submission validation.
- Strong communication, organization, problem-solving, and collaboration skills.
Applications: Accepted on an ongoing basis via the Madrigal Careers site.
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 for 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 including NDA/BLA activities, pooled analyses, ISS/ISE, and responses to regulatory agencies.
- Support development/maintenance of 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.
- Collaborate with CRO partners to ensure deliverables 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 degree preferred).
- 10+ years of relevant pharmaceutical/biotech experience, including prior regulatory submission experience.
- Strong SAS programming (including SAS Macro development); R programming a plus.
- Knowledge of regulatory guidance and industry standards (ICH, GCP).
- In-depth CDISC knowledge (SDTM, ADaM) with extensive clinical trial implementation experience.
- Advanced statistical concepts for clinical data analyses.
- Experience overseeing CRO-delivered programming.
- Preferred: NDA/BLA submission support, Define.xml, and submission validation.
- Strong communication, organization, problem-solving, and collaboration skills.
Applications: Accepted on an ongoing basis via the Madrigal Careers site.