The Principal / Associate Director Statistical Programmer is an individual contributor responsible for leading and/or supporting multiple programming activities for Madrigal Pharmaceuticals across all phases of clinical development. This role will work closely with the Senior Director, Statistical Programming, statisticians, and external CRO partners to ensure all assigned programming deliverables are completed with high quality and aligned with company standards.
The incumbent will translate statistical objectives into relevant work products, establish programming strategies, and ensure quality execution. The position will combine hands-on programming, development of programming plans, and contribution to regulatory submissions and related documents. In addition to technical execution, the individual will coordinate with biostatisticians, programmers, and CRO partners on the execution of statistical programming deliverables. The individual may partner with the Statistics Lead to manage programming activities for assigned studies or programs, ensuring timelines and quality expectations are met.
Responsibilities:- Lead and contribute to statistical programming activities across multiple clinical studies and development programs.
- Develop, validate, review, and maintain SAS programs used for data access, transformation, analysis, reporting, and regulatory submission activities.
- Review CRO deliverables including SDTM, ADaM, tables, listings, and figures (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 including NDA/BLA activities, pooled analyses, integrated summaries of safety and efficacy (ISS/ISE), and responses to regulatory agencies.
- Support the development, implementation, and maintenance of programming standards, macros, automation tools, QC procedures, SOPs, working instructions, and submission processes.
- Participate in process improvement and automation initiatives to improve programming efficiency, quality, and scalability, including evaluation of AI-enabled solutions.
- Collaborate with CRO partners to ensure deliverables are completed according to 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 total relevant experience in the pharmaceutical/biotech industry with prior regulatory submission experience
- Strong SAS programming experience including SAS Macro development; knowledge of R programming is a plus.
- Understanding of regulatory guidance and industry standards including ICH and GCP.
- In-depth knowledge of CDISC data standards including SDTM and ADaM models, with extensive implementation experience in clinical trials.
- Advanced understanding of statistical concepts supporting clinical data analyses.
- Prior experience overseeing programming activities delivered by CRO partners.
- Experience supporting NDA/BLA submissions, Define.xml, and submission validation processes preferred.
- Strong communication, organizational, problem-solving, and collaboration skills in a cross-functional environment.
Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $180,000 - $219,000 per year. We comply with all applicable minimum wage laws.
All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.
