Senior Director, Biostatistics Immunology/Inflammation/Ophthalmology

Location
Tarrytown, New York, US
Posted
Jul 13, 2018
Ref
10212BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

The Biostatistics and Data Management Group is looking for a Sr. Director in the Immunology/Inflammation/Ophthalmology Therapeutic Focus Areas. The Sr. Director directs statistical support and provide statistical leadership for all areas of clinical development, and has responsibility for strategic and operational activities. Promote development of key staff responsible for individual projects or areas. Implement and maintain policy for recruitment of high potential staff. Assisting VP, BDM, in the development and implementation of departmental scientific policies, operational guidelines, and administrative structure. Responsible for project staffing and for appropriate resource allocation consistent with corporate priorities. Incumbent could serve as senior research expert, with demonstrated ability to be leader within CD&RA and within field for specific statistical methodology or application.

Responsibilities:

Determines in conjunction with department Vice President, 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.

• 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, Topline Results, 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.

• Active research interest in area related to clinical trial. Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group. Participates in Regeneron task forces and cross-functional operational excellence initiatives.

Requirements:
o Works in a changing and busy environment. Exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks. Works independently - self directed, high energy and strong work ethic. High degree of creativity, latitude and attention to detail required.
o Demonstrated strong leadership, project management, teamwork, and interpersonal skills
o Excellent presentation skills
o Experience and proven ability leading and managing major process and technology initiatives with utilization and impact across multiple functional groups
o Broad knowledge and superior understanding of advanced statistical concepts and techniques
o Outstanding ability and skills to effectively represent Biostatistics and Data Management in interaction with senior management or cross-functional committees
o 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
o Thorough working knowledge of regulatory guidelines on drug development, regulatory submissions, and statistical practice
o Understanding of the drug discovery and development process, regionally and globally
o Strong administrative skills
o SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery)
o May report to a VP or above. Requires the ability to influence others to achieve results. Manage subordinate supervisors.
o Also acceptable - Ph.D. in statistics or related discipline with 12+ 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

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.