Process Development Statistician / Data Analytics Engineer
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POST DATE 8/10/2016
END DATE 10/11/2016
JOB DESCRIPTIONNovavax, Inc. (Nasdaq: NVAX) is a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants. Using innovative proprietary recombinant nanoparticle vaccine platform technology, we produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats. Our vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate recombinant proteins critical to disease pathogenesis. Our product pipeline targets a variety of infectious diseases with clinical vaccine candidates for respiratory syncytial virus ( RSV ), seasonal influenza, pandemic influenza and Ebola virus ( EBOV ). We have additional preclinical stage programs for a variety of infectious diseases. Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden and employs over 500 individuals dedicated to developing novel vaccines to address infectious disease.
We are seeking a statistician with extensive data analytics experience to automate the analysis of the routine development and manufacturing data. This data scientist will be involved in the direct support of upstream and downstream process development, analytical method development, formulations, scale up, tech transfer, and manufacturing.
Responsibilities include but are not limited to:
Assist with statistical support for a variety of activities and implement appropriate statistical methods within Process Development.
Implement scientifically and statistically sound capabilities to automate historical data trending, stability analysis, range calculations, comparability analysis, etc.
Support statistical design and analysis of process characterization studies, analytical assay development, and validation using the DOE methodology.
Evaluate and set appropriate acceptance criteria for analytical methods and manufacturing processes.
Perform outlier identification, equivalence test for parallelism, confidence intervals, and variance component analysis.
Develop scripts to validate analysis software (e.g. JMP) on cGMP computers.
Mentor, teach, and train colleagues in statistical methodologies.
Represent PD on cross-functional teams and in presentations to senior management.
Prepare technical reports and presentations
Manage one's projects effectively, and meet deadlines with high quality of standards.
Explain experimental designs and statistical concepts to non-statisticians.