Associate Director Statistical Programming Jobs in Wayne, PA

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.

Madrigal's medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR- agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

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.

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com.

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site.

Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to HR@madrigalpharma.com.