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Biostatistician II/III

Novavax

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Gaithersburg, MD
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Job Description

As posted by the hiring company

Job Overview:

**Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.**

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu™, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

 

We are seeking a Biostatistician II or III to join our team in Gaithersburg, MD (or remotely) who will work directly with a lead statistician and provide timely and quality biostatistical support for a variety of tasks related to clinical studies and regulatory submissions.  The ideal candidate will have a thirst for learning and understanding the world of vaccines development, possess awareness of statistical methodologies used in a clinical trial setting, and be a self-starter enthusiastic to work in a fast-paced setting.  This position will be filled at a level commensurate with experience.

 

Responsibilities include but are not limited to:

  • Assists in the review of statistical sections of clinical protocols for appropriate statistical methodology for the specific trial, including selection of study design, sample size, and analyses.
  • Prepares or reviews statistical analysis plans and tables/listings/figures shells.
  • Provide statistical and/or programming support for ad-hoc and post-hoc analyses for purposes as diverse as responses to regulatory authority requests, publications, or internal decision-making
  • Writes specifications to produce data sets, tables, figures, and listings for submissions, publications, and internal needs.
  • Prepares or reviews statistical sections for relevant background documents for regulatory agencies.
  • Provides programming support to programming team when it is needed for the validation of clinical study tables and listings.
  • Write code for generating graphs for external dissemination, simulation based power calculations, and development of statistical analysis macros.
  • Reviews database design, CRFs, and edit checks.
  • Performs other duties as requested to meet company milestones

 

Minimum requirements:

  • Master’s Degree in Statistics, Biostatistics, or equivalent degree with at least 2 years of experience in a pharmaceutical company (pharma), biotech, or clinical research organization (CRO); or Bachelor’s Degree in Statistics with at least 5 years of experience in such a setting.
  • Coursework in key statistical areas including sample size determination, binary and continuous models, time-to-event analyses.
  • Awareness of current ICH guidance pertinent to clinical development.
  • Able to thrive in a fast-paced team environment and work independently on projects.
  • Is a good team player. Has good business ethics.
  • Effectively manages one’s projects and meets deadlines while maintaining high quality standards.
  • Good communication and presentation skills. Ability to communicate statistical concepts.
  • Thorough and up-to-date working knowledge of statistical software packages. Hands-on programming experience. Two or more years SAS programming experience (Base SAS, SAS/STAT, SAS/GRAPH, and SAS macro language) and other statistical software (e.g. R or JMP) in pharma/biotech/CRO setting.
  • Experience with CDISC is preferred.

 

 

 

Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

 

Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

 

Equal Opportunity Employer/Veterans/Disabled

 

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

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