Novartis Hiring for Principal Biostatistician job in Princeton Full Time

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 resultsWhat 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 / e

The pay range for this position at commencement of employment is expected to be between $136,800 – $205,200; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.