If you find science, speed, and success exhilarating, you have come to the right place.
Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.
Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
Summary of the Position:
The Statistics Manager leads the CMC Statistics team, directly supports all our nonclinical groups, and provides guidance in the utilization of appropriate statistical methodology to scientists and management at Novavax.
Responsibilities include but are not limited to:
- Manage and develop team of CMC statisticians and lead statistical efforts throughout CMC.
- Provide sound strategic, scientific, and statistical input to support our nonclinical research and development projects, through design of experiments and by using appropriate statistical methodology and sample size.
- Prepare statistical analysis plans; analyze experimental and historical data.
- Create design of experiments and perform various types of statistical analyses to develop predictive models and optimize conditions for processes, methods, and drug product/drug substance storage.
- Perform stability analysis to identify degradation rates and expiration dates.
- Prepare the statistical section of technical reports and presentations.
- Engage in discussions and research to ensure the central place of applied statistics in research, development, quality, and validation projects.
- Manage multiple projects effectively, and meet deadlines with high quality of standards
- Explain statistical designs and concepts to non-statisticians
- Meet company milestones
- A degree (preferably Masters) in Statistics/Biostatistics, Bioengineering, Chemical Engineering, or a related field, with at least 5 years of relevant experience.
- Sound knowledge of theoretical and applied statistics is required, preferably with an emphasis on experimental design in biotechnology, statistical process control, analytical method development, process characterization, formulation development, stability, power calculations, etc.
- The candidate should have hands-on experience with using and scripting statistical software packages including JMP, SAS, and R.
- Familiarity with ICH guidelines.
- Experience in the drug development field is preferred.
- Must be an effective and proactive leader, team player, able to thrive in a fast-paced team environment, and also work independently on projects.
- Excellent interpersonal, oral, and written communication skills.
- Mentorship ability to influence team members and communicate statistical concepts across functions.
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.
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)