Senior Biostatistician, Gene Therapy Trials & Regulatory

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

Job summary

Krystal Biotech in Pittsburgh seeks a Senior Biostatistician to drive statistical input for clinical development across genetic medicines.

You will design trials, develop SAPs, review CDSRs, and partner with Clinical, Regulatory and Medical teams to support regulatory submissions and post-marketing activities.

The role emphasizes GxP, FDA, ICH, and GCP compliance and collaboration with external vendors.

Qualifications

• Master's or PhD in Biostatistics or a related field.
• 5+ years of biostatistics experience in pharma, biotech or CRO settings.
• Experience with regulatory submissions and working with external vendors is preferred.

Responsibilities

• Provide statistical input for trial design, analysis and reporting.
• Develop and review SAPs, protocols and clinical study reports.
• Oversee statistical outputs and partner with cross-functional teams for result interpretation.
• Support regulatory submissions and post-marketing activities.
• Ensure compliance with GxP, FDA, ICH and GCP standards.

Skills

Clinical trial design

Regulatory knowledge

SAS/R programming

Cross-functional collaboration

Education

Master's or PhD in Biostatistics or related field

Job description

Krystal Biotech in Pittsburgh seeks a Senior Biostatistician to drive statistical input for clinical development across genetic medicines.

You will design trials, develop SAPs, review CDSRs, and partner with Clinical, Regulatory and Medical teams to support regulatory submissions and post-marketing activities.

The role emphasizes GxP, FDA, ICH, and GCP compliance and collaboration with external vendors.