Senior Statistical Programming Contractor

Job TitleSenior Statistical Programming ContractorReports To (title)Senior Director Biostatistics and AI/MLSolid SummarySolid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich’s ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. The Company is also focused on developing innovative libraries of genetic regulators and other enabling technologies with promising potential to significantly impact gene therapy delivery cross-industry. Solid is advancing its diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases. For more information, please visit  www.solidbio.com . Position SummaryThe Senior Statistical Programming Contractor will be responsible for leading and executing statistical programming activities to support early-phase clinical trials and regulatory submissions for our gene therapy programs.Key Duties & AccountabilitiesThe Senior Statistical Programming Contractor will Conduct a regulatory submission using R with responsibilities to leave the development, validation, and maintenance of programs for the creation of SDTM and ADaM datasets and TFLs in compliance with CDISC standards. Prepare documentation for clinical trials and regulatory filings including TFL shells and SDTM/ADaM specifications. Participate in the development of standard operating procedures and working instructions. Participate in the development and implementation of AI/ML solutions, including automated clinical trial monitoring and reporting. Collaborate across multiple drugs and indications cross-functionally with Biostatistics, Data Sciences, Medical Writing, Regulatory Publishing, and Clinical Operations to ensure data deliverables meet regulatory timelines and internal quality standards Core Competencies Required Proficiency with AWS and Posit. Strong knowledge of data engineering tools such as Python, R and SQL for data processing. Familiarity with Git, Docker, and SAS. Understanding of the drug development process and associated regulatory requirements. Exposure to healthcare data standards (e.g., CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM). Exposure to big data technologies and handling. Knowledge of machine learning operations and model deployment. Knowledge: Education, Experience, & Skills: A master’s degree in statistics, mathematics, computer science or other equivalents. SAS and R programming experience in a pharmaceutical or biotech setting. Knowledge in CDISC including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as in industry standards for electronic submission of data to regulatory agencies. Travel CommitmentNoneRole Location(HQ, Hybrid, Remote, NC, etc.)Remote