Associate Director, Biostatistics
Company: Sanofi
Location: Bridgewater
Posted on: June 26, 2022
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Job Description:
Position Overview:Provide leadership and guidance as the lead
statistician on one or more project team(s) in late phase I&I
disease areas, accountable for all methodological and statistical
aspects of project(s). Act as statistical consultant within
company. Major Duties and Responsibilities:Lead one indication in
late phase I&I disease areas development.With minimal direction
from group head, direct statistical support and provide scientific
leadership for the responsible project.Accountable for statistical
aspects of clinical development plans, studies and submissions
activities (when applicable), including quality, relevance to
external stakeholders (e.g. regulatory authorities, medical
journals), and scientific validity.Mentor people working on the
project.Promote teamwork, quality, operational efficiency, and
innovation.Create productive work environment.Ensure project team
compliance with SOPs and departmental standards.Plan and track
project activities, timelines, and resource use.Provide
justification for planned resource needs.Seek to optimize resource
utilization thru efficient and well-managed resource allocation and
across projects or areas.Effectively utilize external groups, e.g.
CROs or data monitoring committees (DMC).Capacity to respond to
unscheduled increase in project workload.Provide technical guidance
and mentoring to junior staff.Ensure productive collaborations with
other functions in the aligned project team and with other
statistics project leaders and in communicating with senior
leadership.Represent statistics in regulatory meetings.Represent
statistics to participate (and lead if applicable) in scientific or
technology working groups or cross function initiatives.Contribute
to operation process optimization and provide inputs to statistics
standards.Required Education/Experience:PhD in statistics or
related discipline with at least 6 years of pharmaceutical
experience.Demonstrated strong project/study management,
interpersonal and communicationskill.Broad knowledge and good
understanding of advanced statistical concepts and techniques.Broad
knowledge of pharmaceutical clinical development.Broad experience
in clinical development or post-marketing activities such a
submissions, interactions with regulatory agencies or other
external stakeholders.Experience in the I&I therapeutic area
desired.Ability to represent Sanofi in cross-company activities
such a consortiums or professional associations.At Sanofi R&D
North America, we deliver meaningful solutions for patients. We
transform science into breakthrough, best-in-class and
first-in-class medicines and vaccines. We believe in creating a
diverse and inclusive workforce - and workplace - which brings
together the collective brainpower of over 2,000 colleagues and
provides you with an exciting place to grow and develop. We set the
bar high, and we deliver. Join us and together we will build on our
trusted legacy of breakthroughs for society.Sanofi Inc. and its
U.S. affiliates are Equal Opportunity and Affirmative Action
employers committed to a culturally diverse workforce. All
qualified applicants will receive consideration for employment
without regard to race; color; creed; religion; national origin;
age; ancestry; nationality; marital, domestic partnership or civil
union status; sex, gender, gender identity or expression;
affectional or sexual orientation; disability; veteran or military
status or liability for military status; domestic violence victim
status; atypical cellular or blood trait; genetic information
(including the refusal to submit to genetic testing) or any other
characteristic protected by law.As a healthcare company and a
vaccine manufacturer, Sanofi has an important responsibility to
protect individual and public health. All US based roles require
individuals to be fully vaccinated against COVID-19 as part of your
job responsibilities.According to the CDC, an individual is
considered to be "fully vaccinated" fourteen (14) days after
receiving (a) the second dose of the Moderna or Pfizer vaccine, or
(b) the single dose of the J&J vaccine. Fully vaccinated, for
new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO
START DATEGD-SALI-SAPDNAt Sanofi diversity and inclusion is
foundational to how we operate and embedded in our Core Values. We
recognize to truly tap into the richness diversity brings we must
lead with inclusion and have a workplace where those differences
can thrive and be leveraged to empower the lives of our colleagues,
patients and customers. We respect and celebrate the diversity of
our people, their backgrounds and experiences and provide equal
opportunity for all.PDN-9665175c-bdcf-42b2-81e5-f5b3578459e0
Keywords: Sanofi, Trenton , Associate Director, Biostatistics, Executive , Bridgewater, New Jersey
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