Regeneron Pharmaceuticals, Inc

Associate Director, Biostatistics - Genetic Medicine

Regeneron Pharmaceuticals, Inc • $176K — $287K *
Warren, MI 48089In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
More than 3 months ago
Job Overview by Ladders

Qualifications

  • PhD or equivalent degree in statistics/biostatistics (6+ years in pharma) or MS degree (11+ years).
  • Experience in hematology, immuno-oncology, or related therapeutic areas preferred.
  • Expertise in time-to-event (TTE) analysis methodologies.
  • Proficient in drug discovery and development processes.
  • Strong leadership and influencing capabilities in cross-functional team dynamics.
  • Proven ability to thrive in fast-paced environments with critical thinking and time management skills.
  • Solid knowledge of statistical analysis and clinical trial design.

Responsibilities

  • Lead Biostatistics efforts within Global Clinical sub-teams.
  • Design and analyze clinical trials in collaboration with cross-functional teams.
  • Prepare regulatory interaction materials, including analysis plans and presentations.
  • Drive process improvement initiatives and author new/revised SOPs.
  • Evaluate and recommend statistical methodologies and software tools.
  • Communicate results effectively through presentations and reports.
  • Conduct research on innovative statistical methods and provide training for non-statisticians.

Benefits

  • Opportunity for mentorship and leadership in a biostatistics department.
  • Exposure to drug development processes on a global scale.
  • Engagement in regulatory interactions with health agencies.
  • Participation in professional associations and conferences.
  • Involvement in innovative research activities.
Full Job Description

This position is for a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development. 

In this role, a typical day might include: ​

The incumbent will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions.  The incumbent will represent statistical issues in regulatory agency meetings.  The incumbent will lead the development and delivery of training to non-statistical colleagues, lead the development of new infrastructure and processes, and be active in representing the company in professional associations, conferences, and publications.  As an Associate Director, the incumbent will be responsible for mentoring and overseeing less experienced statisticians, with the potential to manage full-time staff. 

This role might be for you if can: ​

  • Represent Biostatistics at Global Clinical sub-teams. 

  • Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.

  • Lead contributions to the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc.

  • Lead and contributes to process improvement and technical working groups and sets timelines and expectations for the deliverables.  Authors new/revised SOPs and contributes to cross-functional EPIC workstreams. 

  • Evaluate appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.

  • Prepare presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies.  Co-presents findings to management. 

  • Is involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians. 

To be considered for this opportunity, you must have the following:

  • PhD or equivalent degree in statistics/biostatistics with >6 years of experience in the pharmaceutical industry OR MS degree in statistics/biostatistics with >11 years of experience

  • Preferred: Hematology, IO, non-oncology, Multiple Myeloma experience or similar Therapeutic Area.

  • Time to Event (TTE) experience.

  • Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.

  • Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment. 

  • Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills.

  • Solid knowledge of statistical analysis methodologies, experimental and clinical trial design

  • Expertise in statistical software

#GDBDMJobs

Salary Range (annually)

$176,100.00 - $287,300.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ
REGN
* Ladders Estimates

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