Senior Biostatistician

TL;DR

Senior Biostatistician (Clinical Research): Leading statistical analysis and study design for clinical trials with an accent on CDISC standards, sample size calculations, and complex data programming. Focus on ensuring statistical accuracy in clinical study reports, mentoring junior staff, and collaborating with cross-functional teams to advance drug and device development.

Location: Must be based in the United States. Supports remote work with a preference for hybrid collaboration for those near office locations.

Company

hirify.global provides expert consulting and clinical research solutions to biotech, med device, and pharmaceutical organizations across the complete product lifecycle.

What you will do

• Independently develop and review statistical analysis plans and shells.
• Perform sample size calculations and randomization specifications.
• Develop programs for datasets, listings, tables, and graphs using SAS or R.
• Review SDTM and ADaM domains to ensure data quality and standardization.
• Mentor and train junior biostatisticians on statistical methodologies.
• Collaborate with internal and external clients to address project-related statistical issues.

Requirements

• Advanced degree (MS or PhD) in statistics or a closely related field.
• 5 to 8 years of experience in clinical trial design and analysis.
• Proven experience in the outsourcing industry.
• In-depth knowledge of CDISC standards (SDTM and ADaM).
• Advanced programming skills in SAS or R.
• Excellent English communication skills.

Culture & Benefits

• Commitment to diversity, equity, and inclusion.
• Supportive environment for professional growth and mentorship.
• Collaborative team culture with a focus on results.
• Flexible work arrangements including remote and hybrid options.