Senior Biostatistician

Location: United States; remote work is supported, with hybrid work encouraged for employees within a reasonable commute of an office.

Company

hirify.global provides consulting solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Lead statistical activities for clinical trials, including study design, statistical analysis plan development, and statistical analysis.
• Provide statistical expertise to clinical operations, data management, regulatory affairs, and external partners.
• Develop and review clinical study protocols and case report forms to support appropriate statistical analysis.
• Prepare and quality-check statistical reports, tables, listings, and graphs.
• Develop and maintain SAS programs in line with SOPs, good programming practices, and regulatory guidelines.
• Maintain statistical processes and SOPs, monitor industry standards, and mentor junior statisticians.

Requirements

• Ph.D. or M.S. in Biostatistics.
• At least 3 years of relevant work experience.
• Required experience in the outsourcing industry.
• Experience with clinical trial design, sample size calculations, and statistical analysis.
• Ability to program in SAS and/or R, with experience in CDISC data structures such as SDTM and ADaM.
• Knowledge of statistical methodologies and regulatory requirements for clinical trial analysis and reporting.

Culture & Benefits

• Remote work is supported, with in-person collaboration encouraged where practical.
• Work is conducted in cross-functional and collaborative teams.
• Commitment to diversity, equity, inclusion, and equal employment opportunity.
• Applications are personally reviewed by the recruitment team rather than screened by AI tools.

Hiring process

• Applications are personally reviewed by a member of the recruitment team.
• Applicants receive an outcome regarding their application.