Senior Biostatistician

Job overview

The Senior Biostatistician role is onsite and full-time in Pittsburgh, PA. Compensation is not specified. The position joins Krystal Biotech’s Clinical Development team and provides statistical support across clinical-stage programs. The biostatistician contributes statistical expertise throughout clinical product lifecycles, from study design and analysis through regulatory submissions and post-marketing activities. The role partners with Clinical, Regulatory, Medical, CROs, and other teams to interpret and communicate reliable study results.

What you'll do

• Provide statistical input into clinical trial and study design
• contribute to endpoint selection, sample-size calculations, analysis populations, randomization, and methods
• author and review statistical sections of protocols and analysis plans
• develop or oversee statistical output specifications
• perform or oversee efficacy and safety analyses
• support regulatory submissions and responses
• review datasets and vendor analyses
• lead assigned studies and oversee CRO deliverables
• contribute to study reports, regulatory documents, publications, abstracts, presentations, and pooled analyses
• ensure compliance with FDA requirements, ICH guidelines, GCP, and company procedures.

What we're looking for

Skills & competencies

senior biostatistician

pittsburgh pa

krystal biotech

full-time

clinical development

biostatistics

clinical trials

study design

statistical analysis

regulatory submissions

sas

cdisc

gene therapy

Work arrangement

• Weekend coverage required

Why this role

Requires a master’s degree or PhD in biostatistics, statistics, or a related quantitative field and at least five years of relevant experience; SAS and/or R and CDISC standards experience are listed qualifications.

About the employer

Krystal Biotech is hiring for this role. Industry: Biological Product (except Diagnostic) Manufacturing. Sector: 32.