Associate Director, Biometrics/Statistics

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.

AveXis is seeking an Associate Director within the Biometrics-Statistics group to lead statistical support for pre-clinical research and development programs and CMC activities including pre-clinical in-vivo/in-vitro studies, analytical method development, method qualification/validation, technology transfer/bridging, drug specification, stability and process control. The Associate Director 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. This role will contribute to development of objectives, timeline and completion of milestones associated with specific projects, build effective relationships with peers and managements across functions. And participate in development of departmental process and infrastructure, as well as cross-functional team activities.

Responsibilities

• Provide strategic statistical leadership and expertise to project teams on the development and implementation of proper study design, statistical analysis and data interpretation.
• Lead statistical support for R&D and 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 R&D and CMC problems.
• Participate in development of intra- and inter-department process and infrastructure.
• Design and conduct statistical trainings.
• Supervise and coach junior statisticians providing technical leadership.

Qualifications

• MS or PhD in statistics or other related field with high statistical content.
• Minimum of 6 (for PhD) or 8 (for MS) years of relevant industry experience in drug research and development environment.
• Solid understanding in experimental design, statistical methodologies and statistical 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 and experience in US and global regulatory submissions.
• Working experience in GxP environments.
• Exhibit superior oral and written communication skills.
• Efficiently work and collaborate across teams and function areas.
• Demonstrate mentorship and leadership skills.
• Experience providing independent technical leadership and effectively coaching more junior statistician.
• 10% travel may be required.

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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