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.
The Sr. Manager/ Associate 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 protocols and submissions, including quality, relevance t- regulatory perspective, and scientific validity. Responsible for facilitating career development of direct reports and assisting VP, BDM and/or Sr. Director, Biostatistics, with creation and implementation of policies. May have management responsibility. In some cases incumbent could serve as department leader in specific technical area.
- With minimal direction from departmental management, assume leadership role for providing statistical support t- one or more project teams in the creation of a clinical development plan (CDP), study designs, and production of individual protocols. Work with other BDM members or consultants t- develop effective statistical approaches applicable t- project. Produce or review individual statistical analysis plan (SAP) and planned integrated summaries.
- Interact with the clinical / regulatory functions t- define study endpoints and perform relevant sample size calculations. Learn key clinical and regulatory considerations, ensure that planned statistical methods are applicable, and communicate important statistical considerations t- clients.
- Provide guidance, either personally or through a junior member of the statistical team, on definition and documentation of derived variables needed t- produce planned TFL. Assume responsibility for accuracy of derived variables. Effect consistency of data collection and analysis within project.
- Oversee production of the statistical analyses according t- SAP. Oversee preparation of the statistical methods and results sections for CSR and overall summaries. Provide guidance t- the clinical and regulatory teams regarding conclusions and inferences from the data package. Serve as company statistical representative at regulatory or external meetings.
- Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek t- optimize resource utilization.
- Provide technical direction and mentoring t- staff. Maintain awareness of industry standards and regulatory requirements and communicate within team. Encourage personal development in the context of project work. Learn and apply techniques t- promote teamwork, quality, and motivation.
- Active research interest in area related t- 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.
Education Background and experience-
Ph.D. in statistics or related discipline with 8-10+ years of experience in the biotechnology, pharmaceutical or health related industry, including significant interactions with regulatory bodies, history of successful management (2+ 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 t- specific problems or tasks. Works independently - self-directed, high energy and strong work ethic. High degree of creativity, latitude and attention t- detail required.
- Demonstrated strong leadership, project management, teamwork, and interpersonal skills
- Excellent verbal, written & presentation skills
- Broad knowledge and superior understanding of advanced statistical concepts and techniques
- Experience with application of technical principles, theories, and concepts t- pharmaceutical clinical development and life cycle management
- Familiarity and experience with regulatory guidelines for drug development, submissions, and statistical practices
- Understanding of the drug submission and approval process regionally and globally
- Proven ability t- effectively represent Biostatistics and Data Management in multidisciplinary meetings
- Experience managing direct reports, contractors, teams, and external agencies, such as CROs, consultant groups, and research committees
- Proven ability t- inspire and empower others
- Sought out for advice by others at senior levels
- Ability t- work independently
- SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery)
This is an opportunity t- 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 t- combining good science & good business.
T- all recruitment agencies:
Regeneron is using the agency management company, Candex - www.candex.com . Please, n- phone calls or emails t- any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies t- any employee at Regeneron via-email, the internet or in any form and/or method without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. N- fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means.
Regeneron is an equal opportunity employer and is an affirmative action employer.
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