Senior Biostatistician

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 are not specified.