Principal Statistician

Location
Bannockburn, IL, US
Posted
Jul 31, 2021
Ref
6218
Hotbed
BioMidwest
Required Education
Masters Degree/MBA
Position Type
Full time
Overview

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

The Principal Statistician, leads statistical support for research groups with activities including pre-clinical in-vivo/in-vitro/biodistribution studies, analytical method development, method qualification, technology transfer, and process development. May include real-world evidence (RWE), market access, HEOR and medical affairs studies

Responsibilities
  • Applies statistical principles and techniques to provide strategy and solutions to a wide range of challenging problems in the gene therapy drug research and development environment.
  • Contributes to development of objectives, timelines and completion of milestones associated with specific projects.
  • Provides statistical expertise to research and early development project teams on the development and implementation of proper study design, statistical analysis and data interpretation.
  • May Lead responsibility for ensuring statistical integrity of RWE data and analytical outputs from a range of third party RWE data partners.
  • May have opportunity to represent the business in public fora on issues related to cutting edge statistical techniques relevant to advanced therapies and complex emerging RWE global evidence requirements.
  • Acts as lead statistician for multiple projects and participate in reviewing and writing study protocols and technical reports.
  • Supports preparation of regulatory submissions such as IND and BLA and responses to regulatory queries.
  • Develops novel statistical methods to solve challenging research and early development issues.
  • Participates in the development of intra- and inter-department processes and infrastructure.
  • Designs and conducts statistical training.
  • Builds effective relationships with peers and managements across functions.
  • Participates in development of departmental process and infrastructure, as well as cross-functional team activities.
  • Provides independent technical leadership
  • Other related duties as assigned.

Qualifications
  • MS or PhD in statistics or other related field with high statistical content.
  • 5 (for PhD) or 7 (for MS) years of relevant pharmaceutical and biotech industry experience in a drug research and development environment.
  • 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.
  • Familiar with regulatory guidance, US and international standards such as FDA, EMA, ICH and USP.
  • Exhibit superior oral and written communication skills.
  • Proficiency using statistical software (SAS, R, Minitab, JMP, Prism etc.)
  • Efficiently work and collaborate across teams and function areas.
  • Strong ability align statistical considerations with complex clinical, RWE, access and commercial value demonstration challenges inherent to a first global wave of gene therapies.

The level of this position will be based on the final candidate's qualifications.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, 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!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

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.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

#LI-AM1