Senior Biostatistician

Scorpion Therapeutics; 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

Role

Senior Biostatistician supporting clinical development at Krystal Biotech, focusing on genetic medicines across multiple therapeutic areas including rare diseases and gene therapy.

Responsibilities

• provide statistical input for trial design, analysis, and reporting
• develop and review statistical analysis plans, 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

Qualifications

• Master’s or PhD in Biostatistics or related field
• 5+ years of biostatistics experience in pharma, biotech, or CRO settings
• expertise in clinical trial methodologies, regulatory processes, and statistical programming (SAS/R)
• experience supporting regulatory submissions and working with external vendors preferred

HighValue

• involvement in clinical trials supporting gene therapy, biologics, or specialty therapeutics
• post-IND or post-approval stages, regulatory documentation, and possibly rare disease or personalized medicine

WorkSetup

based in Pittsburgh; collaboration across Clinical, Regulatory, Medical teams; role emphasizes study design, data analysis, and regulatory support.

Travel requirements

Travel requirements are not specified.