Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines 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 Senior Principal Programmer to join our team in Gaithersburg, MD to gain invaluable experience working directly with the Biostatistics group.
Responsibilities include but are not limited to:
- Leading programming activities for CSR and regulatory filing related tasks, including SDTM/ADAM and TFL readiness, in Phase I - Phase III clinical trials for seasonal flu and COVID19 vaccines.
- Collaborate with project statisticians to support other functional areas to perform statistical analyses or data tabulations of clinical data.
- Support creation and maintain of department SOPs.
- Provide input as appropriate into specifications of data structures and database applications to ensure adherence to the standards data storing and management.
- Responsible for quality control and quality audit of SAS software programming deliverables.
- Manage programming activities by external vendors for outsourced studies and contract programmers.
- Supervise junior programmers and provide guidance.
- S. degree in Math/Statistics, Computer Science, or medical related field.
- At least 7 years SAS programming experience (Base SAS, SAS/STAT, and SAS macro language) on clinical trial data in biotech/pharmaceutical industry, or in a CRO servicing the pharmaceutical industry.
- At least 5 years SAS programming experiences in creation/validation SAS datasets and TFLs per SAP or Table Shell/Specs for CSR.
- Worked as lead or principal programmer role on Phase II or III studies for at least 2 years.
- Programming experience in producing outputs for periodical safety report such as SRT, DSMB, DSUR or ClinicalTrials.gov, or outputs to support publications in clinical department.
- Familiar with CDISC guidance and be able to independently create CDISC SDTM/ADAM domains, and associated specs, from clinical data.
- Excellent project management skills, able to work comfortably with tight deadlines.
- Experienced with filing (NDA/BLA) or vaccine clinical trials is preferable.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.
Novavax, Inc. offers a base salary, annual bonus, stock options, 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, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.