Senior Biostatistician (Medical)

TL;DR

Senior Biostatistician (Medical): Leading statistical activities and strategy for clinical trials with an accent on SAP authoring and regulatory compliance. Focus on overseeing statistical deliverables, interpreting analysis outputs, and collaborating with cross-functional teams within Immunology or other therapeutic areas.

Location: Remote (United States)

Company

Global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Lead and provide statistical support for clinical studies, primarily within Immunology or other therapeutic areas.
• Oversee statistical strategy and deliverables as the lead statistician on assigned studies.
• Author and review key statistical documents, including Statistical Analysis Plans (SAPs) and Analysis Database Specifications (ADS).
• Review and interpret analysis outputs to ensure accuracy, quality, and regulatory compliance.
• Collaborate with cross-functional teams, including Clinical, Programming, Data Management, and Regulatory.
• Provide guidance and oversight to statistical programmers and communicate results to stakeholders.

Requirements

• MS or PhD in Statistics, Biostatistics, or a related field.
• Must be based in the United States.
• Strong experience in Immunology or other therapeutic area clinical studies.
• Hands-on experience writing SAPs and Analysis Database Specifications.
• Proficiency in SAS programming.
• Experience working in a CRO, pharmaceutical, or biotech environment.

Nice to have

• Experience leading Phase II–III clinical trials.
• Prior interaction with regulatory agencies.
• Experience mentoring junior statisticians or programmers.

Culture & Benefits

• Permanent role offering the security of a global CRO combined with the focus of a single sponsor.
• Commitment to continuous training to develop and maintain highly-qualified personnel.
• Inclusive work environment that values diversity in gender, race, beliefs, and ethnicities.
• Company culture that maintains below-industry-average turnover rates.

Hiring process

• CV submission and acknowledgement.
• Initial phone interview for candidates meeting the requirements.