• Senior Director, Biometrics - Statistics

    Job Locations US-CA-San Diego
    Posted Date 1 week ago(4/8/2019 5:01 PM)
    Job ID
    2019-3257
    # of Openings
    1
    Category
    Research and Development
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

     

    AveXis, Inc., a Novartis Company, is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

     

    AveXis is seeking a Senior Director of Biometrics/Statistics to join the AveXis-San Diego site to serve as the head of Biometrics/Statistics group. Provide and oversee statistical support for the R&D and CMC organizations including Analytical Development, Research, and Quality Control in strategic planning, study design, decision making, data interpretations and implementation of innovative solutions in support of successful IND filings and commercial filing and post-market life cycle activities of the enriched gene therapeutic pipeline at AveXis. 

    Responsibilities

    • To lead, manage and build a high-performing Biometrics group that supports the R&D and CMC functions.
    • Team with the functional lead and stake holders to lead the strategic and operational planning of the statistical contributions to the drug development plans.
    • Provide statistical support to pre-clinical research, translational sciences, product development, CMC and operations.
    • Build internal working standards for statistical works so that all works are carried out with regards to AveXis standards and external regulations.
    • Promote, investigate, develop and implement novel statistical approaches for relevant statistical issues and/or regulatory guidance and/or value demonstration.
    • To provide leadership and direction to improvement of projects, activities and initiatives and drive the implementation of best statistical practices.
    • Develop and maintain relationships with external opinion leaders, consultants and collaborative groups.
    • Ensure projects are successfully delivered in terms of scientific leadership and resourcing.

    Qualifications

    • MSc/PhD in Statistics or Mathematics (containing a substantial statistical component).
    • Minimum of 9 (for PhD) or 12 (for MS) years of experience in pharma/biotech or other relevant areas with successful track record as SME in both CMC and R & D arena.
    • Experience in all stages of drug development including but not limited to pre-clinical research, translational sciences, product development, CMC and operations of biologics such as antibodies and vaccines with experience in gene therapeutic modality as plus.
    • In depth knowledge of the technical and regulatory requirements related to the role.
    • Expert of statistical methodology, modeling, design, data interpretation and visualization in drug development.
    • Experience of regulatory interactions and IND/BLA/EMA submissions of biologics drugs.
    • Excellence in translating scientific problems into statistical/data science solutions.
    • Excellence in applying expertise to complex problems, problem solving and quality focus.
    • Proven ability to work with cross-functional teams by timely delivering high quality statistical packages with right strategies, planning and execution with “can do” attitude and team work spirit.
    • Excellent written and verbal communication skills demonstrating great leadership in leading and coordinating the statistical activities across sites and building relationships.

     

    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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