Biostatistician

Job Locations US-IL-Bannockburn
Posted Date 2 weeks ago(2/7/2018 1:01 PM)
Job ID
2018-1118
# of Openings
1
Category
Clinical Development

Overview

Ready to join a team committed to moving gene therapies into the clinical setting 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.  We are at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.

 

Position Summary

AveXis, Inc. 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 currently seeking a Biostatistician.  This role will support statistical needs and provide statistical expertise to help guide strategy, design and execution of clinical development programs for a dynamic, fast-paced clinical stage biotechnology company.  This person will be a key contributor to study design and analysis of clinical data related to company’s development programs and support of regulatory and publications functions.  In this role, the selected candidate will participate in a variety of duties related to execution of biostatistics deliverables and guide biostatistics consultants/CRO activities.  The successful candidate will ensure departmental goals and deliverables are met.  This individual will plan, analyze, and summarize the results of individual clinical studies or groups of studies (integrated summaries).   The incumbent will oversee programming of, and/or review statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with AveXis Standard Operating Procedures (SOPs) or study specific guidelines.

Responsibilities

  • Efficiently and effectively coordinate statistical activities for multiple projects simultaneously, including providing expertise and guidance to relevant aspects of protocol development.
  • Develop statistical analysis plans (SAPs), end of study clinical study reports (CSR), and other relevant biostatistics activities.
  • Interact with project team, as well as key internal and external stakeholders.
  • Maintain awareness of project tasks and effectively communicate the status of such tasks to the Head of Biostatistics and Head of Clinical Development.
  • Program in SAS and/or R to create output tables and/or listings as needed, including in presentation-ready tables, listings, and figures.
  • Provide guidance for external (CRO) statisticians.
  • Perform other responsibilities as required by the Department and participate in process improvement initiatives.

Qualifications

  • Masters or doctoral degree in biostatistics or statistics with 4+ years of experience to successfully perform the key responsibilities of the role.
  • Experience in statistical design, analysis, and reporting methodology for basic and complex studies along with experience in contributing to statistical activities in clinical research.
  • Excellent programming skills in SAS and R, including designing and developing output tables, listings, and figures.
  • Must have experience with clinical and operational elements of pharmaceutical development.
  • Understanding of the principles of ICH GCP and regulatory requirements is essential.
  • Candidates must have excellent analytical, verbal, and written presentation skills with a thorough working knowledge of SAS, R, and other relevant statistical software as well as working knowledge of Microsoft Office applications including Word, Excel, PowerPoint, and Visio.
  • Excellent organizational and analytical skills, strong oral and written communication skills, and able to work in a high paced, timeline driven setting.
  • Highly effective interpersonal skills and the ability to continually demonstrate poise, tact, and diplomacy are necessary.

 

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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