What are the responsibilities and job description for the Senior Biostatistician position at Krystal Biotech, Inc.?
About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.
Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.
Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.
Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.
Position Overview:
We are seeking a highly motivated Senior Biostatistician to join our Clinical Development team in Pittsburgh. This role will provide broad statistical support across several clinical-stage programs, partnering with Clinical, Regulatory, and Medical along with other cross-functional teams. This individual will support study design, analysis, interpretation, and reporting throughout product lifecycles, from clinical development through regulatory submission and post-marketing activities.
Responsibilities
Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.
Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.
Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.
Position Overview:
We are seeking a highly motivated Senior Biostatistician to join our Clinical Development team in Pittsburgh. This role will provide broad statistical support across several clinical-stage programs, partnering with Clinical, Regulatory, and Medical along with other cross-functional teams. This individual will support study design, analysis, interpretation, and reporting throughout product lifecycles, from clinical development through regulatory submission and post-marketing activities.
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.
- Master’s degree or PhD in Biostatistics, Statistics, or a related quantitative discipline.
- 5 years of relevant biostatistics experience within pharmaceutical, biotechnology, CRO, or clinical research environments.
- 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.
- Experience supporting approved products, post-marketing studies, label expansion, or lifecycle management activities preferred.
- Proficiency with SAS and/or R.
- Experience with CDISC standards, including SDTM and ADaM.
- Experience working with CROs and external statistical programming partners.
- Experience in rare disease, gene therapy, biologics, or other specialized therapeutic areas preferred.
- Excellent communication, analytical, organizational, and project management skills.
- Ability to thrive in a fast-paced environment and manage shifting priorities.