Principal Biostatistician

The Principal Biostatistician at eClinical Solutions plays a pivotal role in providing high-level consulting services for statistical analysis and reporting within clinical trials. This position is integral to the company's mission of accelerating clinical development through expert data services and the elluminate Clinical Data Cloud. The role involves close collaboration with clients and internal teams to ensure the delivery of high-quality statistical outputs.

Key responsibilities include developing and finalizing statistical analysis plans, creating randomization schedules, and conducting comprehensive statistical analyses. The Principal Biostatistician will also validate programming deliverables, develop SAS programs for analysis datasets, and generate trial-specific reports such as tables, listings, and graphs. Additionally, the role requires mentoring statistical programmers and ensuring compliance with industry quality standards and guidelines.

Candidates should possess a Master's degree in Statistics, Biostatistics, or equivalent experience, along with over five years of experience in the pharmaceutical or biotechnology industry. Proficiency in clinical study design, randomization schedule development, and a strong understanding of ICH guidelines and regulatory requirements are essential. Experience with CDISC data models, such as SDTM and ADaM, and excellent verbal and written communication skills are also required.

eClinical Solutions offers a comprehensive benefits package, including health insurance, retirement plans, and professional development opportunities. The company fosters a collaborative and innovative work environment, providing employees with opportunities for growth and advancement within the organization.