Associate Director\Director Biostatistics

Company Name:
Company Description
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 markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Associate Director/Director, Biostatistics provides leadership and guidance as the statistical expert on a project team or within a therapeutic area. For one or more projects, be accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. Act as key statistical consultant within company. Responsible for project staffing, resource planning and allocation within therapeutic area(s). Responsible for facilitating career development of direct reports and assisting VP, BDM and with creation and implementation of policies. May have management responsibility. In some cases incumbent could serve as department leader in specific technical area.
Major duties:
Determines in conjunction with department Vice President, department goals, and resource allocation.
Oversee statistical support to multiple project teams. Collaborate with clinical and regulatory leads in defining general strategic approach, creating clinical development plans (CDP), and producing individual protocols. Work independently, or with other BDM departmental members or consultants, to develop effective statistical approaches applicable to project.
Oversee execution of statistical analyses, preparation of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries. Review and approve topline results memos and statistical conclusions. Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Ensure statistical representation at regulatory or other external meetings.
Provide general guidance on definition and documentation of key derived variables needed to support production of tables, figures, and listings (TFL). Effect consistency of data collection and analysis.
Plan and track project activities, timelines, and resource use across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity.
Ensure mentoring and development of staff. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation.
Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOP. Within area of control, update procedures or practices as needed to remain in compliance.
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.
Experience and Required Skills:
Required Education and Experience:
Ph.D. in statistics or related discipline with 10+ years of progressive experience in in the biotechnology, pharmaceutical or health related industry, including significant interactions with regulatory bodies, history of successful management (2-4 plus years), and expertise in one or more therapeutic areas
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.
Demonstrates strong leadership, project management, teamwork, and interpersonal skills
Broad knowledge and superior understanding of advanced statistical concepts and techniques
Ability to innovatively apply technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development
In-depth understanding of the regulatory drug submission / approval process
Ability to effectively represent Biostatistics and Data Management in multidisciplinary or cross-functional meetings
Experience with managing direct reports, contractors, teams, and external agencies, such as CRO, consultant groups, and research committees
Ability to recruit, retain, motivate, and develop highly qualified persons
Sought out for advice by others at senior levels
Ability to work in a fully self-directed manner
SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery)
Requires the ability to influence others to achieve results. May manage subordinate supervisors.
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 Regenerons 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, disability status, protected veteran status, or any other characteristic protected by law.

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