Principal / Associate Director, Statistical Programming

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.

#J-18808-Ljbffr