Senior Director, Biostatistics

Solid Biosciences•Boston, MA

4d•$289,900 - $307,700

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 position reports to the VP, Head of Data Science & Biostatistics and partners with Clinical Development, Clinical Operations, Data Management, Statistical Programming, Regulatory Affairs, Medical Writing, Translational Sciences, and external partners to support scientifically rigorous, operationally feasible studies aligned with regulatory expectations. The Senior Director will shape development plans, endpoint and evidence-generation strategies, trial designs, analyses, and interpretation. The role requires experience addressing statistical challenges in rare disease and advanced therapeutic development, such as small populations, heterogeneous disease progression, natural history data, external controls, and clinically meaningful endpoint selection. The position also oversees outsourced biostatistics and statistical programming activities, and communicates statistical strategies and risks to technical and nontechnical stakeholders. The role is based in Charlestown, Massachusetts, with hybrid or remote work options. The stated base compensation range is $289,900–$307,700. Regular employees are eligible for short- and long-term incentives, including cash bonus and equity incentive opportunities.

Requirements

PhD in Biostatistics, Statistics, or a related quantitative discipline is 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 approaches for rare disease development.

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 approaches to 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 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 use biomarker, natural history, and other external data sources 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 throughout 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 proactively address statistical and programming risks.
Maintain knowledge of evolving regulatory expectations for rare diseases, gene therapies, and advanced therapeutics, and communicate 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 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 for onsite employees at Hood Park.
Free onsite full-service gym for onsite employees at Hood Park.
Employee parking 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.