Principal Statistician

Location
San Diego, CA, US
Posted
Aug 29, 2020
Ref
5469
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

The Principal Statistician within the Biometrics-Statistics group will function independently and lead 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. This individual will apply 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. The Principal Statistician will contribute to development of objectives, timelines and completion of milestones associated with specific projects.

Responsibilities
  • Provide statistical expertise to research and early development project teams on the development and implementation of proper study design, statistical analysis and data interpretation.
  • Act as lead statistician for multiple projects and participate in reviewing and writing study protocols and technical reports.
  • Support preparation of regulatory submissions such as IND and BLA and responses to regulatory queries.
  • Develop novel statistical methods to solve challenging research and early development issues.
  • Participate in the development of intra- and inter-department processes and infrastructure.
  • Design and conduct statistical training.
  • Build effective relationships with peers and managements across functions.
  • Participate in development of departmental process and infrastructure, as well as cross-functional team activities.

Qualifications
  • MS or PhD in statistics or other related field with high statistical content.
  • Minimum of 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.
  • Provide independent technical leadership.


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

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.

AveXis 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.

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