Senior Director Biostatistics - Rare-Disease Gene Therapy

Solid Biosciences Inc.; Boston (MA); Hybrid; USD 290,000 - 308,000; Full time

Benefits offered by this job

Health and dental programs

401(k) with company match

Employee Stock Purchase Plan

Lunch delivery (onsite)

Onsite gym

Employee parking

Holidays

Job summary

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.

Responsibilities

• 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.

Skills

Statistical leadership

Clinical development

Regulatory submissions

Rare disease experience

Bayesian methods

Causal inference

CRO oversight

R proficiency

SAS familiarity

Education

PhD in Biostatistics or related field

MS with substantial industry leadership experience

Tools

R

SAS

CDISC SDTM/ADaM

Job description

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.