Senior Director, Biostatistics

Solid Biosciences Inc.; Boston (MA); Hybride; USD 290 000 - 308 000; Plein temps

Avantages offerts par ce poste

Health and dental programs

401(k) with company match

Employee Stock Purchase Plan

Lunch delivery (onsite)

Onsite gym

Employee parking

Holidays

Résumé du poste

Solid Biosciences is seeking a Senior Director, Biostatistics to provide strategic statistical leadership across its clinical development portfolio, guiding designs, analyses and interpretation from development planning through regulatory submission.

The ideal candidate will have a PhD in Biostatistics, 12+ years in biopharma, strong experience with rare diseases or gene therapy, Bayesian methods, external controls, and vendor oversight, with proficiency in R and SAS.

Qualifications

• PhD in Biostatistics or related field preferred; MS with significant relevant experience considered.
• Typically 12+ years in biopharmaceutical industry with increasing responsibility in clinical development.
• Experience supporting global health authority interactions and regulatory submissions.
• Experience in rare disease, gene therapy, neuromuscular disease, or other orphan indications preferred.
• Expertise in estimands, multiplicity control, missing data, longitudinal and time-to-event analyses; Bayesian borrowing or adaptive designs preferred.
• Experience leading outsourced biostatistics and CRO oversight; vendor governance.

Responsabilités

• Provide statistical leadership for clinical development programs from planning to regulatory submission.
• Translate objectives into robust trial designs with sample size, randomization, estimands, multiplicity and interim analyses.
• Apply innovative approaches to rare disease development, including external data and Bayesian methods.
• Collaborate with cross-functional teams to use external data sources in decision-making.
• Lead statistical content for protocols, SAPs, trial reports, and regulatory submissions.
• Ensure analyses are reproducible, documented, and aligned with regulatory standards.
• Oversee outsourced biostatistics and programming activities; manage vendor deliverables.

Connaissances

Statistical leadership

Clinical development

Regulatory submissions

Rare disease experience

Bayesian methods

Causal inference

CRO oversight

R proficiency

SAS familiarity

Formation

PhD in Biostatistics or related field

MS with substantial industry leadership experience

Outils

R

SAS

CDISC SDTM/ADaM

Description du poste

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

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

2 days ago Requisition ID: 1159

Salary Range: $289,900.00 To $307,700.00 Annually

Charlestown, Massachusetts / Hybrid / Remote

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.

Key Position Responsibilities

• 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 influence program decisions by communicating complex statistical concepts, risks, assumptions, and alternatives clearly to technical and nontechnical stakeholders.

Experience Requirements

• PhD in Biostatistics, Statistics, or a related quantitative discipline strongly preferred; an MS degree with substantial relevant industry and leadership experience may be considered.
• Typically at least 12 years of biopharmaceutical industry experience with progressively increasing responsibility in clinical development.
• Demonstrated experience supporting global health authority interactions and regulatory submissions, including preparation of statistical content, responses to agency questions, and BLA, NDA, MAA, or comparable filings.
• Experience in rare disease, gene therapy, neuromuscular disease, pediatric development, or other orphan indications strongly preferred, including addressing small populations, disease heterogeneity, natural history comparisons, external controls, and limited concurrent control data.
• Deep expertise in clinical trial design and statistical methods, including estimands, multiplicity control, missing data, longitudinal and time-to-event analyses, sensitivity analyses, and interpretation of efficacy and safety outcomes; experience with Bayesian borrowing, adaptive designs, causal inference, or other innovative rare disease approaches is preferred.
• Experience leading outsourced biostatistics and statistical programming activities, including CRO oversight, vendor governance, and review of external deliverables.
• Strong understanding of global regulatory expectations and relevant guidance, including ICH E9 and E9(R1), CDISC standards including SDTM and ADaM, and regulatory submission data requirements; proficiency with R and familiarity with SAS-based regulatory analysis and submission environments.

At Solid Biosciences, the Senior Director, Biostatistics will have the opportunity to shape statistical and evidence-generation strategies for innovative therapies intended to address serious neuromuscular diseases. This individual will work in a collaborative, patient-focused environment in which scientific rigor, thoughtful innovation, and sound decision-making are central to advancing the clinical portfolio.

Compensation

The base compensation range for this role is: $289,900 - $307,700

Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid’s long term company performance.

Benefits and Solid Advantages

At Solid Biosciences we offer a highly competitive total rewards and benefits package, intended to support all aspects of our employees’ lives and well-being. Additionally, for those employees working onsite at our Hood Park Headquarters, we offer a variety of onsite resources to support those working in our offices.

• Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
• 401(k) program participation with competitive company matched contributions
• Eligibility to participate in Solid’s Employee Stock Purchase Plan
• Mobile phone subsidy for eligible employees
• Tuition Reimbursement
• Vision Coverage
• Life Insurance
• Voluntary Pet Insurance
• Employee Discount Program on Travel, Entertainment, and Services
• Employee Assistance Programs
• Daily Subsidized Lunch Delivery (onsite @ Hood Park)
• Free Onsite Full-Service Gym (onsite @ Hood Park)
• Employee Parking (onsite @ Hood Park)
• 12 Observed Holidays and a winter shut down
• 15-day PTO Policy and a 80-hour rollover YoY