||Aug 09, 2019
||3 yrs- 5 yrs
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.
The Associate Director provides leadership and guidance as the statistical expert on a project team, with minimal direction from Therapeutic Area lead biostatistician. Accountable for all statistical aspects of project studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. May have regional or global management responsibility. In some cases incumbent could serve as technical expert in a particular statistical area or application.
• With general guidance from departmental management, assume leadership role for providing statistical support to a project team, including clinical development plans (CDP) and individual protocols.
• Work with other BDM members or consultants to develop effective statistical approaches applicable to project.
• Interact with the clinical / regulatory functions to define study endpoints and perform relevant sample size calculations.
• Learn key clinical and regulatory considerations, ensure that planned statistical methods are applicable, and communicate statistical perspective to clients.
• Review statistical analysis plan (SAP) and planned integrated summaries for consistency with overall project objectives.
• Produce / coordinate production of statistical summaries, analyses, and related material for submission to regulatory authorities or independent monitoring committees.
• Provide guidance, either personally or through a junior member of the statistical team, on definition and documentation of derived variables needed to produce planned TFL.
• Assume responsibility for accuracy of derived variables. Effect consistency of data collection and analysis within project.
• Oversee execution of the statistical analyses according to the SAP. Advise on relevance and interpretation of proposed ad hoc analyses.
• Prepare statistical methods and results sections for CSR and overall summaries.
• Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the project.
• Act as company statistical representative at regulatory or external meetings.
• Active research interest in area related to clinical trial.
• Advises all direct reports about the procedures surrounding retention of data, records, and information for employees in their group.
Ph.D. in Statistics or related discipline with 8+ years of experience in the experience in the biotechnology, pharmaceutical or health related industry, including some interaction with regulatory bodies and management experience.
• 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.
• Leads by example and manages staff by commitment.
• Self-directed and comfortable working in teams with the ability to work and operate independently within a tight deadline environment.
• High degree of creativity, latitude and attention to detail required.
• Thorough knowledge of pharmaceutical / biotech clinical development
• Ability to produce novel and near optimal clinical development plans through integration of statistical thinking with clinical and regulatory considerations
• Expertise in at least one therapeutic indication, including in-depth knowledge of key endpoints and regulatory guidelines
• Demonstrated knowledge of regulatory guidelines on drug development, NDA submissions, and statistical practices, e.g., CTD guidance, ICH guidelines
• Understanding of the drug approval process worldwide
• Ability to serve as statistical consultant to company staff
• Strong interpersonal and communication skills, experience managing internal team and CROs
• Ability to effectively represent Biostatistics and Data Management in multidisciplinary meetings
• Strong project management and leadership skills, especially with regard to planning, organizing, tracking, and motivating teams
• Ability to anticipate resource needs and participate in planning
• SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery)
May report to a Assoc. Director or above. 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 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. Known for its scientific and operational excellence, Regeneron is a leading science-based