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Manager, Biostatistics

Company: Novavax Inc.
Location: Gaithersburg
Posted on: November 22, 2021

Job Description:

This position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation for a religious belief or a health-related need. 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 Manager, Biostatistics responsible for diligent and quality-focused execution of biostatistical tasks related to clinical studies and regulatory submissions who will work directly with Biostatistics senior management and the Statistical Programming team. The ideal candidate will have previous background in a vaccines development environment, solid awareness and/or understanding of statistical methodologies relevant to a vaccines setting, and be a self-starter with initiative to be able to work in a fast-paced setting with minimal supervision. This position will be filled at a level commensurate with experience. Responsibilities include but are not limited to: * Assists clinical team in designing all NOVAVAX-sponsored clinical trials and prepares all 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 statistical sections of statistical analysis plans. * Prepares statistical sections for relevant background documents for regulatory agencies. * Writes and reviews specifications to create 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. * Provides effective guidance to external partners/vendors. * Manages one's projects and meets deadlines while maintaining high quality standards. * Explains statistical designs and concepts to non-statisticians. * Is a good team player. Has good business ethics and leadership skills. * Performs other duties as requested to meet company milestones including support for Regulatory Affairs, Clinical Immunology, and other functional areas. Minimum requirements: * Master's Degree in Statistics (or equivalent degree) with at least 5 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 4 years of experience in pharma/biotech/CRO. * Experience gained in the main tasks of a project/lead statistician. * 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. Two to three 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 required. 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. #LI-LM1 #LI-Remote

Keywords: Novavax Inc., Washington DC , Manager, Biostatistics, Executive , Gaithersburg, DC

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