Novavax

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.

Job Summary

Conduct statistical programming and related activities in Phase 1 to 4 clinical trials for aggregate, program-level safety assessments.

Essential Functions

• Coordinate and collaborate with other functions including epidemiologists, biostatisticians, data managers, regulatory affairs, etc., to ensure that programming deliverables meet scientific specifications, project timelines, and regulatory requirements.
• Review statistical document including SAP, and TLF Mock shells to provide statistical programming feedback.
• Create integrated safety datasets and derive datasets to address the safety topics of special interests.
• Directly support the analytic requirements of Clinical Safety Statistics projects, including statistical programming for the creation of data and TLFs.
• Develop programming standards, process, and system to streamline Clinical Safety Statistics deliverables and enhance quality, accuracy, and reproducibility.
• Create programing documents, such as, ADaM/SDTM specifications, SOP, guidance, etc., to follow regulatory document requirement, guide other statistical programmers and share best practices.
• Maintain all documentation of programming activities in accordance with SOPs/Guidance/process to ensure traceability and regulatory compliance.

Supervisory Responsibilities

Required Knowledge, Skills, and Abilities

• Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL preferably proficiency with additional statistical software or applications, e.g. R, R Shiny.
• At least 6 years application on clinical trial data for pharma, biotech, or CRO companies.
• Programming experience in producing output for safety reports, such as for the ISS, RMP, IB, DSUR, or ClinicalTrials.gov. 
• Familiar with relevant industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, Pinnacle 21, and FDA guidelines.

Education, Experience, Licenses & Certifications

MS. (BS) degree in Statistics, Biostatistics, Computer Science, Epidemiology, Mathematics, or related field.

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.