Senior Director, Biostatistics

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Clinical Full-Time: FTE 40 hrs. / Full Benefits .25 Charlestown-HQ, Charlestown, MA, US

2 days ago Requisition

Salary Range: $ To $ Annually

Solid 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. We are advancing a 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.

Solid Biosciences is seeking an experienced and strategic Senior Director, Biostatistics to provide statistical leadership across its clinical development portfolio. This individual will serve as the lead statistician for one or more programs and guide statistical strategy from development planning and protocol design through regulatory submission.

Reporting to the VP, Head of Data Science & Biostatistics, the Senior Director will partner closely with Clinical Development, Clinical Operations, Data Management, Statistical Programming, Regulatory Affairs, Medical Writing, Translational Sciences, and external partners to ensure that study designs, analyses, and interpretations are scientifically rigorous, operationally feasible, and aligned with regulatory expectations.

The ideal candidate will bring extensive experience in rare disease or advanced therapeutic development, including statistical challenges associated with small populations, heterogeneous disease progression, natural history data, external controls, and clinically meaningful endpoint selection.

• Provide statistical leadership for clinical development programs from early-stage planning through registrational studies and regulatory submission, shaping development plans, endpoint strategies, evidence-generation plans, and program-level statistical approaches.
• Translate program objectives into statistically robust and operationally feasible trial designs, including strategies for sample size, randomization, estimands, multiplicity, interim analyses, missing data, sensitivity and subgroup analyses, and benefit-risk assessment.
• Apply innovative approaches to rare disease development, including the appropriate use of natural history data, external controls, Bayesian methods, and other external information to address small sample sizes, disease heterogeneity, limited concurrent controls, and evolving standards of care.
• Partner with Clinical Development, Translational Sciences, and external collaborators to leverage biomarker, natural history, and other external data sources in support of clinical development decisions.
• Lead or oversee statistical content for protocols, Statistical Analysis Plans, interim analysis plans, randomization specifications, case report forms, data review plans, table/listing/figure shells, clinical study reports, publications, and related study documents.
• Provide statistical leadership throughout study conduct, including data review, protocol amendments, analysis decisions, exploratory and ad hoc analyses, and interpretation of emerging results, while ensuring analyses are reproducible, appropriately documented, and compliant with regulatory requirements and industry standards.
• Develop and defend statistical strategies for global health authority interactions and submissions, including briefing documents, agency responses, meeting packages, integrated summaries of efficacy and safety, and clear communication of study designs, methods, and results in regulatory meetings.
• Provide strategic and technical oversight of outsourced biostatistics, establishing expectations for quality, timelines, documentation, communication, and issue escalation; review and approve vendor deliverables and proactively address statistical and programming risks.
• Maintain knowledge of evolving regulatory expectations for rare diseases, gene therapies, and advanced therapeutics, and…