Group Head Biostatistics, Dire

Company: Novartis Group Companies
Location: Princeton
Posted on: March 18, 2023

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