Senior Director, Clinical Statistics

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

As a Senior Director, Clinical Statistics, you'll provide strategic statistical leadership for a dedicated therapeutic area. This high-impact role involves shaping clinical development plans, driving innovative trial designs, mentoring talent, and collaborating cross-functionally to deliver cutting-edge solutions. With a focus on operational excellence and regulatory readiness, you’ll play a pivotal role in advancing our mission to bring life-changing therapies to patients worldwide.

How you’ll spend your day

• Consult and advise other statisticians on statistical methodology, trial design, and data analysis strategies
• Responsible for oversight of statistical aspects of the design, implementation, and analysis of clinical studies to support global regulatory submissions, payer submissions and medical affairs
• Collaborate effectively with other functions to contribute to clinical development programs
• Drive the use of novel/innovative clinical trial designs and statistical methodology
• Contribute to decisions regarding processes or operational plans and schedules to achieve department objectives
• Help develop and maintain departmental SOPs and ensure their compliance in daily work
• Represent Global Statistics and Data Science in due diligence activities
• Primarily work at the Functional / Executive level with direct team budget responsibility 

Your experience and qualifications

• Ph.D./MS in Statistics/Biostatistics (or related field).
• MS with a minimum of 10 years of related experience; PhD with a minimum of 8 years of related experience.
• Provide strategic managerial leadership for a single therapeutic area, including:
• Professional development support for the next generation of statistical leaders, succession planning, and ensuring departmental vision, mission, and goals are met.
• Negotiating and influencing key stakeholders within a therapeutic area on the importance and appropriate application of quantitative decision-making in drug development.
• Supporting or co-leading cross-functional alignment (e.g., project leadership, clinical development, clinical pharmacology, regulatory, medical affairs/market access, and GSDS functions) within a therapeutic area spanning multiple disease indications.
• Awareness of industry-wide trends across different disease indications as they apply to regulatory strategies, competitive landscape, and best practices.
• Recognized as a statistical subject matter expert and leader in global submissions within a therapeutic area.
• Sponsor operational efficiencies and technical capabilities to promote an innovative culture, cutting-edge statistical methods, and best-in-class performance metrics for statistical deliverables.
• Build and maintain relationships with key statistical experts within the biopharmaceutical industry.
• Demonstrated ability to work independently, formulate strategy, and drive vision and goals.
• Anticipates problems with proactive mitigation strategies and risk management.
• Expert negotiation skills, with the ability to persuade and inspire teams to take action.
• Serve as a role model and mentor, providing guidance and direction for initiatives, process development, and improvement.
• Excellent presentation and written communication skills, with the ability to interpret statistical findings for non-statisticians.
• Strong organizational and problem-solving skills.
• Demonstrated project and technical leadership qualities, as well as creative and strategic thinking.
• Proficiency in SAS programming; knowledge of R is beneficial.
• Familiarity with relevant ICH, FDA, and CHMP guidelines.
• Experience with regulatory submissions in the US and globally.
• Proven ability to deliver quality products efficiently, with relevant technical and scientific publications preferred.
• Ability to partner with and influence stakeholders across clinical research, development, and global medical affairs.
• A strong individual contributor with excellent writ