Senior Biostatistician

Summary: The Senior Biostatistician role is a remote position requiring over 8 years of experience in biostatistics and statistical programming. The candidate will lead statistical aspects of clinical studies, ensuring compliance with industry standards and mentoring junior staff. Proficiency in SAS and/or R for statistical analysis is essential, along with strong communication and leadership skills. The position is outside IR35 and is expected to last for over 12 months.

Key Responsibilities:

• Lead statistical aspects of clinical studies from design to final reporting
• Review and approve programming deliverables (ADaM datasets, tables, listings, and figures)
• Mentor junior biostatisticians and support team development
• Ensure compliance with industry standards (CDISC, ICH, FDA/EMA guidelines)
• Draft SAP/shell independently
• Work in detail and able to review the TLF
• Excellent communication and leadership skills with cross-functional collaboration experience

Key Skills:

• At least 8 years of experience in biostatistics
• Statistical Programming II experience
• Proven expertise in SAS and/or R for statistical analysis
• Strong communication and leadership skills
• Experience in mentoring junior biostatisticians
• Knowledge of industry standards (CDISC, ICH, FDA/EMA guidelines)

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other