Group Head Biostatistics, Dire
Company: Novartis Group Companies
Location: Princeton
Posted on: March 18, 2023
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Job Description:
351013BR
Group Head Biostatistics, Dire
Job Description
1996! In this year Sandoz initiated the world's first biosimilar
development program. Over 20 years of experience in biosimilar
development have equipped us with extensive knowledge and
outstanding expertise in the development, manufacturing and
commercialization of biosimilar medicines to the healthcare
community and patients worldwide. This opportunity is waiting for
you to contribute to Sandoz success story in the area of
biosimilar.
For our team in Princeton we are looking for a
Group Head - Director Biostatistics Biosimilar (80-100%, m/f/d)
Your responsibilities include, but are not limited to:
* Lead a team of statisticians (3-6 FTEs) within the Sandoz
Biosimilar Clinical Development Department
* Be responsible for recruiting and retaining talents, managing
performance (including objective setting, review of performance and
compensation), and professionally developing and motivating
biostatisticians who act as program and trial statisticians
* Lead on priority setting, workload distribution and resource
planning, with the aim of ensuring both adequate assignment of
resource to projects and balance of workload across the team.
* Be accountable for overall quality and accuracy of the scientific
content of materials produced by the team
* Be accountable for sponsor oversight of trial-related activities
performed by CROs/external partners
* May serve as deputy for the Development Unit Head for key
activities and key meetings
* Act as Program statistician for biosimilar development programs
within cross-functional global development teams
* Provide scientific, strategic and statistical input to clinical
development strategies and trial designs for biosimilar development
programs (including Biomarker, PK, PK/PD and efficacy/safety
studies)
* Champion, drive and implement innovative efficient trial designs
and novel statistical methods within programs
* Independently lead interactions with Health Authorities (e.g.
EMA, FDA, PMDA, NMPA) and key opinion leaders
EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and
take pride in maintaining a diverse environment. We do not
discriminate in recruitment, hiring, training, promotion or other
employment practices for reasons of race, color, religion, gender,
national origin, age, sexual orientation, gender identity or
expression, marital or veteran status, disability, or any other
legally protected status. We are committed to building diverse
teams, representative of the patients and communities we serve, and
we strive to create an inclusive workplace that cultivates bold
innovation through collaboration and empowers our people to unleash
their full potential.
Minimum requirements
* PhD, PharmD or MS with honors in biometrics, statistics,
mathematics, pharmacometrics, clinical pharmacology, or other
quantitative discipline preferred
* PhD with 8+ years' experience preferred OR MS with 12+ years'
experience
* Has advanced knowledge of applying statistics and innovative
approaches Expert knowledge in a variety of statistical areas.
* Has advanced knowledge of applying statistics and innovative
approaches Expert knowledge in at least 2 of the following key
areas in industry and/or academia:
* Design of clinical development programs (including Biomarker, PK,
PK/PD and efficacy/safety studies)
* Application of clinical pharmacology and/or pharmacometrics
methods
* Bayesian trial design and analysis
* Application of Real World Evidence and machine learning in
clinical trials
* Demonstrated Good coaching and mentoring skills
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better
healthcare. We are a company of firsts. 1st to develop an oral
penicillin antibiotic. 1st to develop and launch biosimilars. 1st
to launch an FDA-cleared digital therapeutic. And we never stop
asking: how can we continue to pioneer access in an ever-more
digital and global world?
The answers come when curious, courageous and collaborative people
are empowered to ask new questions, make bold decisions and take
smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar
medicines and a pioneer in digital therapeutics.
Imagine what you could do at Sandoz!
Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity
and inclusion. We are committed to building diverse teams,
representative of the patients and communities we serve, and we
strive to create an inclusive workplace that cultivates bold
innovation through collaboration, and empowers our people to
unleash their full potential.
Hiring decisions are only based on the qualification for the
position, regardless of gender, ethnicity, religion, sexual
orientation, age and disability.
The law provides for severely disabled / equal applicants the
opportunity to involve the local representative body for disabled
employees (SBV) in the application process. If you would like to
request this, please let us know in advance as a note on your
CV.
Join our Novartis Network
If this role is not suitable to your experience or career goals but
you wish to stay connected to learn more about Novartis and our
career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network
Division
SANDOZ
Business Unit
BioPharma SZ
Country
USA
Work Location
Princeton, NJ
Company/Legal Entity
Sandoz Inc
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
Keywords: Novartis Group Companies, Trenton , Group Head Biostatistics, Dire, Other , Princeton, New Jersey
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