Senior Biostatistician

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.

Qualifications

• 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.