Description
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
Senior Principal Biostatistician Biosimilar (80-100%, m/f/d)
1. Study level:
a. Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities.
b. Be responsible for sponsor oversight of trial-related activities performed by CROs/external partners
c. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required.
d. Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate.
e. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required.
2. Project level:
a. May act as program statistician for biosimilar development programs within cross-functional global development teams and represents Biostatistics as part of development plan.
b. 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)
c. Champion, drive and implement innovative efficient trial designs and novel statistical methods within programs
d. Lead planning and execution of innovative statistical analyses and eCTD preparation for regulatory submission and post-marketing activities including publications
e. Collaborate cross-functionally (e.g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables.
f. Significantly contributes to project team preparation for HA Advisory Committees and meetings.
Diversity & Inclusion / EEO
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
What you'll bring to the role
* PhD, PharmD or MS with honors in biometrics, statistics, mathematics, pharmacometrics, clinical pharmacology, or other quantitative discipline preferred (PhD with 3+ years' experience preferred OR MS with 7+ years' experience) Preferred
* Good knowledge and evidence of hands-on experience in at least 3 of the following key areas in pharmaceutical industry, vendors and/or academia:
* Design of clinical development programs (including Biomarker, PK, PK/PD and efficacy/safety studies)
* Clinical efficacy equivalence trials
* Adaptive designs and clinical trial simulation
* Application of clinical pharmacology and/or pharmacometrics methods
* Bayesian trial design and analysis
Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we're proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Sandoz!
Division
SANDOZ
Business Unit
BioPharma SZ
Location
USA
Site
Princeton, NJ
Company / Legal Entity
Sandoz Inc
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
