Executive Director, Late Clinical Development Biostatistics

Summary

The Executive Director, Late Clinical Development Biostatistics provides statistical support and leadership for all areas of late-phase clinical development, and has responsibility for strategic and operational activities. He/She assists and reports to the Vice President Head of Biostatistics & Data Management (BDM), in the development and implementation of departmental scientific policies, operational guidelines, and administrative structure. This role is also responsible for project staffing and for appropriate resource allocation consistent with corporate priorities. Incumbent serves as senior research specialist, with demonstrated leadership within Global Clinical Operations (GCO) and within field for specific statistical methodology or application.
Responsibilities

• Interact with department Vice President to determine department goals and resource allocation.
• Ensure project teams have high-quality statistical support for creation of clinical development plans (CDP), study design, and operational aspects.
• Lead all aspects of statistical reporting and ensure compliance with data submission guidelines, including review of documents, such as SAP, Key Results, CSR, and coordinated summaries.
• Ensure statistical designs, data collection, analysis methodologies and processes to clearly and robustly address the objectives of clinical studies and programs.
• Lead development and optimization of statistical processes focusing on efficiency and quality, while maintaining or exceeding industry best practices.
• Work with senior management to ensure statistical representation in key project decisions and regulatory meetings, and serve as departmental representative on corporate-wide teams.
• Plan and track project activities, timelines, and resource use: Provide justification for planned resource needs and seek to optimize resource utilization across projects or areas.
• Set strategy for how department will improve technical expertise, and ensure direction and mentoring of staff including professional development, training and compliance. Establish teamwork, quality attitude and motivation in the department.
• Lead late-stage clinical development and coordinate all statistical aspects of clinical studies and submissions, relevance to regulatory perspective and scientific validity.
• Identify business problems and establish strategy, in collaboration with Head of BDM, and provide direction for team to craft solutions.
• Possess validated understanding of regulatory guidelines, drug discovery and development process, regionally and globally.
• Alert staff to new or changing standards.
• Within area of control, harmonize policies with departmental guidelines / SOPs and with industry standards, as well as developing polices promoting application of Regeneron Way in work practices.
• Collaborate closely with Regeneron and partners' leaders to influence, shape, and drive strategies related to integrated development programs and regulatory submissions.
• Contribute to Regeneron task forces and cross-functional operational excellence initiatives.
• Actively participate in statistical conferences, sponsor internal staff to be active at external professional meetings, and proactively seek ways to represent company externally.
• Able to influence regulatory agencies, in both product-related forums and more generally in the industry, and work with company to develop a regulatory strategy.
• Supervise performance of team, and proactively address gaps/issues to ensure performance goals/expectations are met.
• Contribute to the long-term success of the company.
• Works closely with senior leaders to establish the Biostatistics department in a leadership role in drug development, and drive how the company approaches product development.
• Be an active member of DPR, PRC. Conduct all pre-PRC and pre-DPR reviews for BDM, within their area of responsibility. Ensure teams have appropriate plans and mentor teams to improve their effectiveness in committee and senior management meetings.

Requirements:
Education:

• PhD in Statistics or relevant field with 13+ years of experience in the biotechnology, pharmaceutical or health related industry, including significant interaction with both FDA and EMEA, history of successful project and people management (6+ years), and expertise in multiple therapeutic areas

Experience:

• Work in a fast-paced environment, with excellent judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards
• Outstanding ability and skills to effectively represent Biostatistics and Data Management in interaction with senior management or cross-functional committees
• Detailed knowledge of clinical development and life cycle management with the ability to innovatively apply technical principles, theories and concepts to drug development leading to regulatory approvals
• Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical practice.
• Excellent verbal and written communication, and presentation skills.
• SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery)

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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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