Your RoleAt the intersection of clinical science, data innovation, and drug development, this role offers a rare opportunity to shape the statistical foundation of life-changing medicines. As a Senior Principal Biostatistician within the Global Biostatistics team, you will serve as a Statistical Subject Matter Expert at the Global or Regional Program study team level - designing, analyzing, and interpreting data from clinical and observational studies with a high degree of autonomy. From early development through regulatory submission and lifecycle management, your work will directly influence the scientific integrity and success of clinical programs that matter to patients worldwide.
You will act as statistical subject master expert to collaborate with cross functional teams to contribute to study design, establishing objectives, endpoints, and estimands while evaluating designs through advanced simulations. You will develop and maintain strategic analysis plans, author Statistical Analysis Plans (SAPs) and statistical sections of Clinical Study Reports (CSRs), and perform or oversee statistical analyses across multiple trials - including complex data from biomarkers, genomics, real-world evidence, patient-reported outcomes, digital devices, and imaging.
You will also support regulatory submissions by contributing to the integrated safety and efficacy summary statistical analyses ensuring alignment with ICH, FDA, EMA, and regional guidelines.
Beyond your technical contributions, you will drive innovation within the department by critically appraising and applying emerging technologies, including machine learning, artificial intelligence, and large language models in statistical contexts, and by contributing to business development activities through statistical expertise.
Who You AreBasic / Minimum Qualifications:- Master's degree in a Data Sciences discipline - such as Statistics, Biostatistics, Informatics, Bioinformatics, Mathematics, or Computer Science - with at least 5 years of experience in pharmaceutical or biotechnology clinical development; OR a doctoral degree in a Data Sciences discipline with at least 3 years of equivalent industry experience.
- 3+ years of hands-on programming experience in SAS or R within a clinical development environment.
- Educated in ICH and Good Clinical Practice (GCP) guidelines, with the ability to navigate additional relevant regulatory frameworks (FDA, EMA, and regional authorities).
- Demonstrated ability to apply advanced statistical methods - including missing data strategies, multiple testing, and complex endpoint modeling - in drug development or related research.
Preferred Qualifications:- Deep understanding of the biological, genetic, and systemic background of assigned clinical therapeutic areas.
- Experience overseeing vendors and Contract Research Organizations (CROs) in a statistical capacity.
- Familiarity with the critical appraisal and responsible application of machine learning, artificial intelligence, and large language model technologies within biostatistics - including awareness of their limitations, ethical considerations, and governance implications.
- Strong communication skills with the ability to present complex statistical concepts clearly to cross-functional stakeholders, including senior leadership.
Base Pay Range for this position - $122,700 - $184,100The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
