Senior Biostatistician, Gene Therapy Clinical Development

krystalbiotech; Pittsburgh (Allegheny County); On-site; USD 120,000 - 160,000; Full time

Job summary

Krystal Biotech, Inc. is seeking a Senior Biostatistician to join our Clinical Development team in Pittsburgh. You will provide broad statistical support across multiple clinical programs, partnering with Clinical, Regulatory, and Medical teams through development to regulatory submission.

You will design studies, assist with SAPs, and lead statistical analyses for efficacy and safety, ensuring GCP compliance and alignment with FDA expectations in a fast‑paced gene therapy environment.

Qualifications

• Master’s degree or PhD in Biostatistics, Statistics, or a related quantitative discipline.
• 5+ years of relevant biostatistics experience in pharmaceutical, biotechnology, CRO, or clinical research environments.
• Experience supporting clinical trials, S.A.P.s, protocols, and Clinical Study Reports.
• Strong knowledge of trial methodology, statistics, and regulatory expectations.
• Experience with regulatory submissions and FDA interactions preferred.
• Proficiency with SAS and/or R; CDISC SDTM/ADaM familiarity.

Responsibilities

• Provide statistical input into design and execution of clinical trials and studies.
• Contribute to endpoint selection, sample size calculations, analysis populations, and randomization strategies.
• Author and review statistical sections of protocols, SAPs, and study documents.
• Develop specifications for tables, listings, figures, and other outputs.
• Perform analyses of efficacy, safety, and other clinical data.
• Support regulatory submissions, label expansions, and post‑marketing commitments.

Skills

Biostatistics

Clinical trials

SAS

R

CDISC SDTM

CDISC ADaM

Regulatory submissions

Study design

Education

Masters in Biostatistics

PhD in Biostatistics

Tools

SAS

R

Job description

Krystal Biotech, Inc. is seeking a Senior Biostatistician to join our Clinical Development team in Pittsburgh. You will provide broad statistical support across multiple clinical programs, partnering with Clinical, Regulatory, and Medical teams through development to regulatory submission.

You will design studies, assist with SAPs, and lead statistical analyses for efficacy and safety, ensuring GCP compliance and alignment with FDA expectations in a fast‑paced gene therapy environment.