Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: November 25, 2022
The Director of 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. As
the Director of Biostatistics, a typical day might include the
following: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/or Dr.
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.This role might be for you if:
- 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
- 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.To be considered for this opportunity, you must have the
- PhD in Biostatistics, Statistics, Mathematics or related
- 10+ years of experience in the biotechnology, pharmaceutical or
health related industry, including significant interactions with
regulatory bodies, history of successful management (4+ years), and
expertise in one or more therapeutic areas.Does this sound like
you? Apply now to take your first steps toward living the Regeneron
Way! We have an inclusive and diverse culture that provides
comprehensive benefits including health and wellness programs,
fitness centers and equity awards, annual bonuses, and paid time
off for eligible employees at all levels!Regeneron is an equal
opportunity employer and all qualified applicants will receive
consideration for employment without regard to race, color,
religion or belief (or lack thereof), sex, nationality, national or
ethnic origin, civil status, age, citizenship status, membership of
the Traveler community, sexual orientation, disability, genetic
information, familial status, marital or registered civil
partnership status, pregnancy or parental status, gender identity,
gender reassignment, military or veteran status, or any other
protected characteristic in accordance with applicable laws and
regulations. We will ensure that individuals with disabilities are
provided reasonable accommodations to participate in the job
application process. Please contact us to discuss any
accommodations you think you may need.The salary ranges provided
are shown in accordance with U.S. law and apply to U.S. based
positions, where the hired candidate will be located in the U.S. If
you are outside the U.S, please speak with your recruiter about
salaries and benefits in your location.Salary Range (annually)
$182,800.00 - $304,600.00
Keywords: Regeneron Pharmaceuticals, Inc., Newark , Director, Biostatistics, Executive , Basking Ridge, New Jersey
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