Global Senior Real-World Biostatistics Lead

GSK; Upper Providence (Delaware County); On-site; USD 150,000 - 210,000; Full time

Job summary

GSK seeks an Associate Director of Biostatistics to lead strategic initiatives applying advanced biostatistical methods to real-world data (RWD) and generate real-world evidence (RWE) for trials, regulatory submissions, reimbursement, and safety signals.

The role partners with cross-functional teams to develop and optimize RWE strategies for priority assets, ensuring data-driven decisions and robust evidence packages for approvals.

Qualifications

• Ph.D. in Statistics, Data Science, Epidemiology, or related field with 6+ years in pharma/biotech.
• Experience with drug development and applying innovative statistical thinking to achieve objectives.
• Experience with RWD and applying observational study designs and biostatistical principles in clinical research.

Responsibilities

• Lead design and analysis of non-interventional studies with cross-functional teams.
• Guide use of health data sets; define variables and code lists; author technical specs.
• Develop and refine statistical analysis plans; conduct complex analyses and communicate results to stakeholders.
• Support regulatory submissions and safety signals with biostatistical input.

Skills

Biostatistics

RWD experience

R programming

SQL

Causal inference

Communications

Regulatory knowledge

English fluency

Education

Ph.D. in Statistics

Master's degree in Statistics

Tools

R

SQL

Job description

GSK seeks an Associate Director of Biostatistics to lead strategic initiatives applying advanced biostatistical methods to real-world data (RWD) and generate real-world evidence (RWE) for trials, regulatory submissions, reimbursement, and safety signals.

The role partners with cross-functional teams to develop and optimize RWE strategies for priority assets, ensuring data-driven decisions and robust evidence packages for approvals.