Senior Biostatistician — Clinical Trials Lead

Krystal Biotech; Pittsburgh (Allegheny County); Presencial; USD 120 000 - 180 000; Tempo integral

Resumo da oferta

Krystal Biotech, Inc. in Pittsburgh seeks a highly motivated Senior Biostatistician to support our Clinical Development team across multiple programs, from study design to regulatory submission and post‑marketing activities.

You will partner with Clinical, Regulatory and Medical teams, oversee statistical analyses, develop SAPs, and ensure compliance with FDA, ICH and GCP while guiding CROs and vendors. This role demands strong communication and project management in a fast‑paced environment.

Qualificações

• 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.

Responsabilidades

• 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.

Formação académica

Master's degree or PhD in Biostatistics, Statistics, or a related quantitative discipline

Ferramentas

SAS

R

CDISC SDTM/ADaM

Descrição da oferta de emprego

Krystal Biotech, Inc. in Pittsburgh seeks a highly motivated Senior Biostatistician to support our Clinical Development team across multiple programs, from study design to regulatory submission and post‑marketing activities.

You will partner with Clinical, Regulatory and Medical teams, oversee statistical analyses, develop SAPs, and ensure compliance with FDA, ICH and GCP while guiding CROs and vendors. This role demands strong communication and project management in a fast‑paced environment.