Solid Biosciences · 10 hours ago
Principal Biostatistician
United States
Full-time
Remote
Senior Level, Lead/Staff
$170K/yr - $215K/yr
6+ years expSolid Biosciences is a precision genetic medicine company focused on advancing gene therapy candidates for rare diseases. The Principal Biostatistician will lead statistical design and analysis for clinical trials, collaborating with various teams to ensure scientific rigor and regulatory compliance.
BiotechnologyGeneticsHealth CareMedical
Responsibilities
Lead statistical design and analysis for Phase I-II clinical trials and observational studies (sample size, randomization, adaptive features, estimands)
Develop and review Statistical Analysis Plans (SAPs), protocols, interim analysis plans, and regulatory submission documents (CSR, eCTD statistics modules)
Oversee implementation and quality control of statistical deliverables; ensure reproducible analyses and adherence to standards (CDISC SDTM/ADaM, controlled terminologies)
Perform advanced analyses (survival, longitudinal, mixed models, Bayesian methods, multiplicity adjustments, subgroup and sensitivity analyses)
Review vendor and CROs outputs and ensure statistical integrity
Contribute to SOPs, templates, methodological guidance, and cross-functional working groups
Communicate complex statistical concepts clearly to clinical, regulatory, and operations teams
Qualification
Required
MS or PhD in Biostatistics, Statistics, Mathematics, Epidemiology, or related quantitative field (PhD preferred)
Typically 8+ years (MS) or 6+ years (PhD) of biostatistics experience in pharmaceutical/biotech industry
Demonstrated experience leading statistical design and analyses for late-stage clinical trials and regulatory submissions
Strong knowledge of clinical trial methodology, regulatory statistical requirements, and CDISC standards
Proven track record of authoring and reviewing SAPs, statistical sections of clinical study reports, and submission packages
Proficiency with R and other statistical software (e.g., Python, Stata)
Experience with CDISC SDTM and ADaM standards and related implementation tools
Familiarity with clinical trial data capture systems and data flow (EDC, eCRF)
Knowledge of ICH guidelines (E9, E3, E8), FDA/EMA statistical expectations, and GxP
Strong leadership, project management, and stakeholder engagement skills
Excellent written and verbal communication; ability to explain technical topics to non-statisticians
Critical thinker, detail-oriented, and able to work independently and collaboratively in cross-functional teams
Ability to manage multiple programs, timelines, and priorities concurrently
Preferred
PhD preferred
Experience with rare disease indications and/or pediatric populations
Experience with novel statistical methodology (platform trials, master protocols, adaptive designs, Bayesian frameworks, synthetic or external control arms)
Training across analytical disciplines preferred (data science, bioinformatics, statistical programming)
Experience implementing AI/ML algorithms for improved decision-making preferred
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
Daily Subsidized Lunch Delivery (onsite @ Hood Park)
Free Onsite Full-Service Gym (onsite @ Hood Park)
Employee Parking (onsite @ Hood Park)
Company
Solid Biosciences
Solid Biosciences is a life science company that conducts research for the treatment of Duchenne muscular dystrophy.
51-200 employees
H1B Sponsorship
Solid Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (3)
2023 (2)
2022 (4)
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$810.3MKey Investors
Ultragenyx PharmaceuticalPerceptive AdvisorsJP Morgan
2025-02-18Post Ipo Equity· $200M
2024-01-08Post Ipo Equity· $109M
2022-09-30Post Ipo Equity· $75M
Leadership Team
Alexander Cumbo
CEO and President
Kevin Tan
Chief Financial Officer
Recent News
Pharmaceutical Technology
2026-01-16
Company data provided by crunchbase