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Associate Director, Biostatistics

Employer
Regeneron Pharmaceuticals, Inc.
Location
Basking Ridge, New Jersey
Start date
Nov 30, 2021

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Discipline
Science/R&D, Biostatistics
Required Education
Doctorate/PHD/MD
Position Type
Consultant
Hotbed
Pharm Country, Best Places to Work

Job Details

The Associate Director 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 to 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.

A typical day may include:

  • With minimal direction from departmental management, assume leadership role for providing statistical support to 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 to develop effective statistical approaches applicable to project. Produce or review individual statistical analysis plan (SAP) and planned integrated summaries.
  • 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 important statistical considerations to clients.
  • 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 production of the statistical analyses according to SAP.  Oversee preparation of the statistical methods and results sections for CSR and overall summaries.  Provide guidance to 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 to optimize resource utilization.
  • Provide technical direction and mentoring to 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 to promote teamwork, quality, and motivation.

This role may be for you:

  • You can work effectively in a changing and busy environment. 
  • You are able 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.
  • You can work independently as a self directed, high energy individual with strong work ethic. 
  • You have demonstrated strong leadership, project management, teamwork, and interpersonal skills 
  • You have excellent verbal, written & presentation skills 
  • You have broad knowledge and superior understanding of advanced statistical concepts and techniques
  • You have experience with application of technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
  • You have familiarity and experience with regulatory guidelines for drug development, submissions, and statistical practices
  • You have an understanding of the drug submission and approval process regionally and globally
  • You can effectively represent Biostatistics and Data Management in multidisciplinary meetings
  • You have experience managing direct reports, contractors, teams, and external agencies, such as CROs, consultant groups, and research committees
  • You have proven ability to inspire and empower others
  • You are sought out for advice by others at senior levels

To be considered, you must have a PhD in Statistics or related discipline with at least 8 years of relevant experience in biotechnology, pharmaceutical or health related industry including experience with regulatory bodies. SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery) is also needed.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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