Senior Statistician Consultant (Vaccines & Infectious Diseases)

TL;DR

Senior Statistician Consultant (Biostatistics): Leading statistical strategy, analysis, and reporting for clinical development programs in Vaccines & Infectious Diseases with an accent on protocol development and regulatory submissions. Focus on designing clinical trials, developing Statistical Analysis Plans (SAPs), and ensuring CDISC standards compliance for FDA/EMA submissions.

Location: Remote (United States)

Company

hirify.global is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, and medical device companies.

What you will do

• Lead statistical input for clinical trial design, including protocol development and sample size calculations.
• Develop and review Statistical Analysis Plans (SAPs) and provide oversight of analyses for Phase I–IV studies.
• Collaborate with cross-functional teams in Clinical, Data Management, and Programming departments.
• Interpret study results and contribute to the creation of Clinical Study Reports (CSRs).
• Support regulatory submissions to the FDA and EMA, including responding to health authority queries.
• Guide and review the work of statistical programmers regarding SDTM/ADaM and TLFs to ensure CDISC compliance.

Requirements

• Master’s or PhD in Statistics, Biostatistics, or a related field.
• 5+ years of experience in clinical trials within a pharmaceutical or CRO environment.
• Strong experience specifically in Vaccines & Infectious Diseases.
• In-depth knowledge of clinical trial methodology and statistical principles.
• Proven experience with regulatory submissions (FDA/EMA).
• Proficiency in SAS.

Nice to have

• Knowledge of R programming.

Culture & Benefits

• Opportunity to work directly for a single sponsor while maintaining the security of a global CRO.
• Strong focus on quality, professional development, and a supportive work culture.
• High-trust environment with a commitment to diversity and inclusivity.
• Access to continuous training to maintain high levels of expertise.

Hiring process

• Initial CV screening.
• Phone interview as the first step for qualified candidates.