Senior Biostatistician

Krystal Biotech•Pittsburgh, PA

2d•Onsite

About The Position

Krystal Biotech is a company focused on the discovery, development, manufacturing, and commercialization of genetic medicines for diseases with high unmet medical needs. Founded in 2016, Krystal utilizes a patented gene therapy platform, innovative manufacturing capabilities, and a patient-centric commercialization model. The company has received FDA approval for VYJUVEK® and is advancing a pipeline in various therapeutic areas. Krystal is headquartered in Pittsburgh, PA, with global teams and satellite offices. They are seeking individuals who are caring, fearless, passionate about their work, and uphold scientific integrity.

Requirements

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.
Proficiency with SAS and/or R.
Experience with CDISC standards, including SDTM and ADaM.
Experience working with CROs and external statistical programming partners.
Excellent communication, analytical, organizational, and project management skills.
Ability to thrive in a fast-paced environment and manage shifting priorities.

Nice To Haves

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.
Experience in rare disease, gene therapy, biologics, or other specialized therapeutic areas preferred.

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.