Associate Director, Chemistry, Manufacturing and Controls Statistics

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Associate Director, Chemistry, Manufacturing and Controls (CMC) Statistics provides statistical expertise in support for broad activities within CMC domain across R&D, Quality and Technical Operation organizations for both pipeline programs and commercial products.

Responsibilities

• Collaborates and provides statistical input on broad CMC activities including but not limited to:
  • Analytical method development;
  • Method qualification/validation;
  • Technology transfer/bridging;
  • Drug specification, product stability;
  • Process improvement, process validation;
  • Continuous process verification;
  • Process control and quality by design.
• Provides strategies and solutions to a wide range of challenging problems in the gene therapy drug development and manufacture environment using/applying statistical principles and techniques.
• Builds effective relationships with peers and managements across functions and organizations.
• Participates in development of departmental process and infrastructure, as well as cross-functional team activities.
• Provides 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.
• Leads statistical support for CMC projects and participate in reviewing and writing study protocol and technical reports.
• Supports regulatory strategy and preparation of regulatory submissions such as IND and BLA and participate in meetings with regulatory agencies.
• Develops novel statistical methods to solve challenging issues in gene therapy CMC domain.
• Participates in development of intra- and inter-department process and infrastructure.
• Designs and conducts statistical trainings to non-statisticians.
• Other related job duties as assigned.

Qualifications

• MS or PhD in statistics or other related field with high statistical content with 6 (for PhD) or 8 (for MS) years of relevant industry experience in Biotech or Pharmaceutical drug development and manufacture 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.
• 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.
• Working experience in GMP environments.
• 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.
• Approximately 10% travel.

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.

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.

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