Aug 16, 2022

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
Your responsibilities:
1. 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.

2. 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.

3. Other:

a. Establish and maintain collaborative working relationships and effective communication within Biostatistics department, Sandoz BCD, Global Program Teams, as well as with Novartis Advanced Methodology, Novartis CD&A
b. Explain statistical concepts in an easily understandable way to non-statisticians and provide relevant statistical interpretation and justification of analysis results

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
• 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
 Advanced statistical modelling (e.g. evaluation of separate treatment effects in combination treatment regimens)
 Application of Real World Evidence and machine learning in clinical trials
• Proficiency in use of statistical software packages (e.g. SAS, R)
• Clinical, pharmacological and therapeutic knowledge
• Good interpersonal and communication skills (verbal and writing) to bridge scientific and business needs, integrating quantitative sciences

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!
The post holder will use his experience and knowledge to design clinical development programs within and interdisciplinary team. They will contribution to the development plan and align the requirements of worldwide health authorities to create efficient design which demonstrate the equivalence of pharmacometric and efficacy endpoints.

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
BioPharma SZ
Princeton, NJ
Research & Development
Full Time
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Senior Principal Biostastician

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