Expert - Manager, CMC Statistics

Job Description Summary

Job Description

#LI-Hybrid

Location: East Hanover, NJ

Key Responsibilities:

• Provide statistical leadership and expertise to CMC functions and project teams on the development and implementation of proper study design, statistical analysis and data interpretation.
• Lead statistical support for CMC projects and participate in reviewing and writing study protocol, analysis plan, statistical report and/or technical reports.
• Develop statistical models to solve challenging issues in cell and gene therapies CMC domain.
• Support regulatory strategy and preparation of regulatory submissions.
• Participate in development of intra- and inter-department process and infrastructure.
• Design and conduct statistical trainings to non-statisticians.

Essential Requirements:

• PhD or MS in statistics or other related field with high statistical content.
• PhD or minimum 2 (for MS) years of relevant industry experience in Biotech or Pharmaceutical drug development and manufacture environment.
• Good understanding in experimental design, statistical methodologies, modeling and simulations. Convey study results with statistical soundness and integrity. Experience in Bayesian statistics is a plus.
• Strong computational skills in statistical packages such as SAS, R, JMP and Minitab.
• Strong oral and written communication skills.
• Efficiently work and collaborate across teams and function areas.
• Demonstrate technical leadership skills.

The salary for this position is expected to range between $103,600 and $192,400 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired