Principal Biostatistician

Solid Biosciences

12h•$170,000 - $215,000•Remote

About The Position

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. We are seeking a Principal Biostatistician to play a pivotal role in the drug development of multiple assets through designing clinical trials, determining appropriate sample sizes, and applying rigorous statistical methods to evaluate whether a treatment is safe and effective. The Principal Biostatistician will collaborate closely with clinicians, data managers, and regulatory teams to ensure that study protocols are scientifically sound and that the resulting data can withstand regulatory scrutiny. The work will involve analyzing complex datasets, interpreting results in a scientifically or clinically meaningful way, and preparing statistical reports that support submissions to agencies like the FDA. In essence, this role will serve as the scientific bridge between raw clinical data and the evidence needed to bring new therapies to patients, a responsibility that demands both technical mastery and strategic insight on required statistical rigor in clinical research. This role will report to the Senior Director of Biostatistics and AI/ML and will be remote.

Requirements

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.

Nice To Haves

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.
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.

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.

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)