Sr Expert, Science & Technology (Principal CMC Statistician)

Job Description

12,000. The number of associates worldwide working together to reimagine medicine! The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.

**The location of this position can be based in San Diego, CA / East Hanover, NJ / Durham, NC. A work location of San Diego, CA is highly preferred. Ability to work remotely 2 days a week, 3 days a week onsite is required.

Novartis is seeking a CMC statistical lead within the Quantitative Science and Statistics (QSS) function in Research and Development (R&D). The CMC statistical lead will be providing statistical expertise in support for broad activities within CMC domain across cell and gene therapies for pipeline programs. Collaborate and provide statistical input on broad CMC activities including but not limited to analytical method development, method qualification/validation, technology transfer/bridging, product specification, product stability, process improvement, process validation, process control and quality by design. Apply statistical principles and techniques to provide strategies and solutions to a wide range of challenging problems in the drug development environment. Build effective relationships with peers and managements across functions and organizations. Participate in development of departmental process and infrastructure, as well as cross-functional team activities.

Your responsibilities will include, but are not limited to:

• Provide strategic 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 and technical reports.
• Support regulatory strategy and preparation of regulatory submissions such as IND and BLA and participate in meetings with regulatory agencies.
• Develop novel statistical methods to solve challenging issues in cell and gene therapies CMC domain.
• Participate in development of intra- and inter-department process and infrastructure.
• Design and conduct statistical trainings to non-statisticians.

Vaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected] .

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:
• MS or PhD in statistics or other related field with high statistical content.
• Minimum of 3 (for PhD) or 6 (for MS) years of relevant industry experience in Biotech or Pharmaceutical drug development and manufacture environment or an equivalent combination of graduate level studies / post doctoral experience.
• Solid understanding in experimental design, statistical methodologies, modeling and simulations. Convey study results with statistical soundness and integrity. Experience in Bayesian statistics is a plus.
• Excellent computational skills in statistical packages such as SAS, R, JMP and Minitab.
• Familiar with regulatory guidance, US and international standards such as FDA, EMA, ICH and USP and experience in US and global regulatory submissions.
• Exhibit superior oral and written communication skills.
• Efficiently work and collaborate across teams and function areas.
• Demonstrate mentorship and leadership skills.
• Provide independent technical leadership and effectively coach junior statistician.
• 10% travel may be required.

The level of this position is commensurate with candidate’s qualifications and relevant experience.

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
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 Novartis!

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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 in order to perform the essential functions of a position, please send an e-mail to [email protected] 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.