Senior Director, Biostatistics Early Clinical Development

The Head, Biostatistics - Early Clinical Development will lead statistical support and provide statistical leadership for early clinical development. 

In this role, a typical day might include:

The incumbent will have responsibility for strategic and operational activities and for assisting the Head, Biostatistics in the development and implementation of departmental scientific policies, operational guidelines, and administrative structure.  The incumbent could also serve as senior research expert, with demonstrated ability to be a leader within Global Development and within the field for specific statistical methodology or application.   The successful candidate should have a track record in leading teams and the ability to effectively structure a function to manage the anticipated growth in the product pipeline. They must also possess excellent communication skills to interface with senior leadership on behalf of the department and work closely with medical study directors to provide and receive direction on clinical programs and have the ability to influence the medical and clinical teams.

This role might be for you if have proven experience:

• Determining Department goals and resource allocation in conjunction with the Department Executive Director.

• Ensure project teams have high quality statistical support for creation of clinical development plans, study design, and operational aspects.

• Work with senior management to ensure statistical representation in key project decisions and regulatory meetings. Serve as departmental representative on corporate‐wise teams.

• Oversee process for statistical reporting. Review critical documents, such as SAP, analysis results presentations, CSR, and integrated summaries. Ensure compliance with data submission guidelines.

• Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization across projects or areas. Effect long‐range planning.

• Ensure technical direction and mentoring for staff. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation. Recruit, develop, and retain high quality staff.

• Maintain awareness of industry standards and regulatory requirements. Alert staff to new or changing standards. Within area of control, harmonize policies with departmental guidelines SOPs and with industry standards. Develop polices promoting application of corporate values in work practices.

To be considered for this opportunity, you must have the following:

• Ph.D. in statistics or related discipline with 10+ years of experience (or MS in statistics or related discipline with 14+ years) 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.

• Active research interests in area related to clinical trial.

• Demonstrated ability to work in a changing and busy environment and to exercise judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.

• Ability to work independently – self‐directed, high energy and strong work ethic. High degree of creativity, latitude and attention to detail required.

• Demonstrated strong leadership, project management, teamwork and interpersonal skills.

• Excellent presentation skills.

• Experience and proven ability leading and managing major process and technology initiatives with utilization and impact across multiple functional groups.

• Broad knowledge and superior understanding of advanced statistical concepts and techniques.

• Outstanding ability and skills to effectively represent Biostatistics and Data Management in interactions with senior management or cross‐functional committees.

• Thorough knowledge of pharmaceutical clinical development and life cycle management; ability to innovatively apply technical principles, theories and concepts to clinical drug development leading to regulatory approvals.

• Thorough working knowledge of regulatory guidelines on drug development, regulatory submissions, and statistical practice.

• Understanding of the drug discovery and development process, regionally and globally.

• Strong administrative skills.

• Ability to influence others to achieve results.

#GDBDMJobs

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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$228,000.00 - $380,000.00