• 01-Jun-2021 to 01-Jul-2021 (EST)
  • Clinical Development
  • Gaithersburg, MD, USA
  • Full Time - Exempt

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.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

We are seeking a Biostatistician II/III, Biostatistics to join our team in Gaithersburg, MD or remotely to gain invaluable experience working directly with the Senior Managers of Biostatistics and the Statistical Programming team. This position will be filled at a level commensurate with experience.

Responsibilities include but not limited to the following:

  • Assists in the review of statistical sections of clinical protocols using appropriate statistical methodology for the specific trial, including selection of study design, sample size, and analyses.
  • Reviews database design, CRFs, and edit checks.
  • Prepares or reviews statistical analysis plans and tables/listings/figures shells.
  • Prepares or reviews statistical sections for relevant background documents for regulatory agencies.
  • Writes specifications for or produce data sets, tables, figures, and listings for submissions, publications, and internal needs.
  • Provides programming support to programming team when it is needed for the validation of clinical study tables and listings.
  • Write codes for generating graphs for external dissemination, simulation based power calculations, and development of statistical analysis macros.
  • Is a good team player. Has good business ethics and leadership skills.
  • Meets deadlines while maintaining high quality standards.
  • Performs other duties as requested to meet company milestones including support for Senior Manager, Biostatistics.

Minimum requirements:

  • Master's Degree in Statistics (or equivalent degree) with at least 2-3 years of experience in a pharmaceutical company (pharma), biotech, or clinical research organization (CRO) servicing the pharmaceutical industry or PhD in Statistics with at least 1-2 years of experience in pharma/biotech/CRO.
  • Knowledge of experimental design for clinical trials, power calculations, simulations, time-to-event analyses, and other methods for assessment of efficacy, safety, and immunogenicity.
  • Familiarity with current ICH guidance pertinent to clinical development.
  • Proven knowledge and expertise in biostatistics and its application to vaccine clinical trials. Solid knowledge and experience in vaccine development process, including evaluation of epidemiologic data for definition of key endpoints and assessment of correlates of risk.
  • Able to thrive in a fast-paced team environment and work independently on projects.
  • Very good communication and presentation skills. Ability to communicate statistical concepts across functions.
  • Thorough and up-to-date working knowledge of statistical software packages. Hands-on programming experience. One to two 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.
  • 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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