Teva Senior Director Clinical Statistics 

United States, Pennsylvania, East Bradford Township 

653193228

As a, 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.

• 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

• 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 written and oral communication skills.

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
• Posting a new req-2024
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

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