Senior Biostatistician – Gene Therapy Clinical Development

Krystal Biotech, Inc.; Pittsburgh (Allegheny County); On-site; USD 120,000 - 180,000; Full time

Job summary

Krystal Biotech, Inc. is seeking a highly motivated Senior Biostatistician to join our Clinical Development team in Pittsburgh.

This role provides broad statistical support across several clinical-stage programs, partnering with Clinical, Regulatory, and Medical teams throughout product lifecycles. You will lead study design, analysis, interpretation, and reporting from development through regulatory submission and post-marketing activities, ensuring compliance with FDA, ICH, and GCP guidelines,

Qualifications

• Master’s degree or PhD in Biostatistics, Statistics, or related quantitative discipline.
• 5+ years of relevant biostatistics experience in pharma, biotech, CRO, or clinical research.
• Experience supporting clinical trials and developing Statistical Analysis Plans, protocols, and Clinical Study Reports.
• Strong knowledge of clinical trial methodology, statistical analysis, and regulatory expectations.
• Experience supporting regulatory submissions and interactions with FDA or other regulatory authorities preferred.

Responsibilities

• Provide statistical input into the design and execution of clinical trials and other studies supporting clinical development and marketed products.
• Contribute to endpoint selection, sample size calculations, analysis populations, randomization strategies, and statistical methodologies.
• Author and review statistical sections of protocols, Statistical Analysis Plans, and other study documents.
• Develop or oversee specifications for tables, listings, figures, and other statistical outputs.
• Perform and/or oversee analyses of efficacy, safety, and other clinical data.
• Support regulatory submissions, label expansions, post‑marketing commitments, and responses to regulatory authority questions.
• Partner with cross‑functional teams to interpret and communicate study results.
• Review datasets, statistical outputs, and analyses produced by internal teams, CROs, and external vendors.
• Serve as statistical lead for assigned studies and oversee CRO and vendor statistical deliverables.
• Contribute to Clinical Study Reports, regulatory documents, publications, abstracts, and presentations.
• Support pooled and integrated analyses across studies and programs, as applicable.
• Ensure statistical activities comply with applicable FDA requirements, ICH guidelines, GCP, and company procedures.

Skills

SAS

R

Clinical trial design

Statistical analysis

Regulatory submissions

CRO coordination

CDISC SDTM/ADaM

Education

Master’s or PhD in Biostatistics

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Krystal Biotech, Inc. is seeking a highly motivated Senior Biostatistician to join our Clinical Development team in Pittsburgh.

This role provides broad statistical support across several clinical-stage programs, partnering with Clinical, Regulatory, and Medical teams throughout product lifecycles. You will lead study design, analysis, interpretation, and reporting from development through regulatory submission and post-marketing activities, ensuring compliance with FDA, ICH, and GCP guidelines,