Senior Director, Biostatistics

Solid Biosciences•Charlestown, MA

About The Position

Solid Biosciences is seeking an experienced, strategic Senior Director, Biostatistics to provide statistical leadership across its clinical development portfolio. The role serves as lead statistician for one or more programs, guiding statistical strategy from development planning and protocol design through regulatory submission. The Senior Director partners with Clinical Development, Clinical Operations, Data Management, Statistical Programming, Regulatory Affairs, Medical Writing, Translational Sciences, and external partners to ensure studies are scientifically rigorous, operationally feasible, and aligned with regulatory expectations. The role focuses on statistical challenges in rare disease and advanced therapeutic development, including small populations, heterogeneous disease progression, natural history data, external controls, and clinically meaningful endpoint selection. The Senior Director will shape development plans, trial designs, evidence-generation plans, analyses, and interpretation, and will provide statistical leadership throughout study conduct and health authority interactions. The position reports to the VP, Head of Data Science & Biostatistics. Solid Biosciences is a precision genetic medicine company advancing gene therapy candidates for rare neuromuscular and cardiac diseases. The company describes its environment as collaborative and patient-focused, with scientific rigor, thoughtful innovation, and sound decision-making central to advancing its clinical portfolio. The position is listed as Charlestown, Massachusetts / Hybrid / Remote.

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.
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 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.

Nice To Haves

Experience in rare disease, gene therapy, neuromuscular disease, pediatric development, or other orphan indications, including addressing small populations, disease heterogeneity, natural history comparisons, external controls, and limited concurrent control data.
Experience with Bayesian borrowing, adaptive designs, causal inference, or other innovative rare disease approaches.

Responsibilities

Provide statistical leadership for clinical development programs from early-stage planning through registrational studies and regulatory submission.
Shape development plans, endpoint strategies, evidence-generation plans, and program-level statistical approaches.
Translate program objectives into statistically robust and operationally feasible trial designs, including sample size, randomization, estimands, multiplicity, interim analyses, missing data, sensitivity and subgroup analyses, and benefit-risk assessment.
Apply appropriate innovative approaches for rare disease development, including natural history data, external controls, Bayesian methods, and other external information.
Partner with Clinical Development, Translational Sciences, and external collaborators to use biomarker, natural history, and other external data in 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 during study conduct, including data review, protocol amendments, analysis decisions, exploratory and ad hoc analyses, and interpretation of emerging results.
Ensure 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 communication of study designs, methods, and results in regulatory meetings.
Provide strategic and technical oversight of outsourced biostatistics, setting expectations for quality, timelines, documentation, communication, and issue escalation; review and approve vendor deliverables and address statistical and programming risks.
Maintain knowledge of evolving regulatory expectations for rare diseases, gene therapies, and advanced therapeutics.
Communicate complex statistical concepts, risks, assumptions, and alternatives clearly to technical and nontechnical stakeholders.

Benefits

Competitive health and dental programs with flexible plan offerings, including FSA and HSA programs.
401(k) program with competitive company-matched contributions.
Eligibility to participate in the 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 for employees onsite at Hood Park.
Free onsite full-service gym for employees onsite at Hood Park.
Employee parking for employees onsite at Hood Park.
12 observed holidays and a winter shutdown.
15-day PTO policy with an 80-hour year-over-year rollover.
40-hour sick policy.
8-hour floating holiday.
Short-term and long-term incentives, including cash bonus and equity incentive opportunities, for regular employees.