Statistical Project Leader

Role Summary

Join the Medical Affairs Biostatistics team as Statistical Project Leader (Associate Director) to drive evidence generation across Phase IIIB & IV clinical trials, observational and prospective real-world evidence studies. You’ll develop innovative statistical solutions to generate and communicate medical evidence to healthcare professionals, payers, and the scientific community while leading cross-functional teams and mentoring statistical talent. You will be supported by a Biostatistics group within the Evidence Generation and Decision Science department to optimize success and have a meaningful impact on patients’ lives.

Responsibilities

• Drive statistical strategy for Medical Affairs studies, including Phase IV trials, observational studies, and statistical expertise on RWE projects
• Lead statistical contribution to Integrated Evidence Generation plans, ensuring scientific rigor, regulatory compliance, and stakeholder relevance
• Independently manage statistical aspects with minimal oversight while engaging leadership on strategic decisions
• Drive innovation by rethinking traditional workflows and implementing cutting-edge statistical methodologies to accelerate evidence generation
• Oversee project planning, timelines, and resources across multiple studies
• Manage relationships with external partners (CROs, academic collaborators, DMCs)
• Partner with Medical Affairs, Clinical Development biostatistics, Pharmacovigilance, Regulatory, HEOR, and other functions to align statistical approaches with business objectives
• Represent Statistics in regulatory interactions and scientific forums
• Proactively identify opportunities to streamline processes and leverage AI-powered solutions to enhance project efficiency
• Mentor junior statisticians and statistical programmers
• Foster a culture of innovation, scientific excellence, and continuous improvement
• Champion quality standards while promoting operational efficiency
• Lead by example in adopting AI and automation tools to transform statistical workflows and unlock significant productivity gains

Qualifications

• 7+ years (MS) or 5+ years (PhD) of pharmaceutical industry experience in clinical trials and/or medical affairs
• Proven track record of delivering results in complex, fast-paced environments
• Strong project/study management, interpersonal and communication skills
• Good knowledge of pharmaceutical clinical development and medical affairs
• Extensive ability to apply advanced statistical analyses using SAS and/or R
• Results-driven mindset with ability to rethink and optimize workflows
• Knowledge or experience with Artificial intelligence or Generative AI is a plus
• Enthusiasm for leveraging AI and Generative AI technologies to reform statistical practices
• MS or PhD degree in Statistics or relevant field
• Languages: Highly effective communication in English, both oral and written

Skills

• Broad knowledge of advanced statistical concepts and techniques, including observational and RWE study applications (causal inference, target trial emulation, pragmatic trials)
• Strong project management, interpersonal and communication skills
• Knowledge of pharmaceutical clinical development and medical affairs
• Proficiency in SAS and/or R for advanced statistical analyses
• Ability to rethink and optimize workflows to drive continuous improvement
• Familiarity with AI or Generative AI is a plus

Education

• MS or PhD degree in Statistics or a relevant field