About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The Research Statistician will join the Statistics group within the Biosimilars Pharmaceutical Sciences organization and will work across the Bioprocess R&D and Analytical R&D groups to provide statistical support in the development of Hospira, a the company company's biosimilar product pipeline. Areas to be supported include drug substance, drug product, and analytical method development. This position reports to the Associate Director, Statistics within the Biosimilars Pharmaceutical Sciences organization.
• Collaborate with scientists to plan meaningful studies/experiments, statistically analyze, and communicate / document the results.
• Demonstrate leadership in influencing and improving workflows by identifying, developing, and applying new quantitative methods as needed to solve problems in biopharmaceutical research.
• Develop and/or teach statistical training courses on topics such as Design of Experiment, Linear/Nonlinear Regression, ANOVA/ANCOVA, etc.
• Provide ad hoc statistical support to internal and external stakeholders.
• Develop novel statistical tools (e.g., Monte Carlo simulation, Bayesian inferences, macros for automating data processing and analyses, multivariate analyses, etc.) to innovate and streamline work streams.
• Pursue business-related research interests and represent the company externally in presentations at conferences and/or publications in peer-reviewed journals.
• Play active role in community of statisticians within the company network and lead/participate in key initiatives.
• M.S. or Ph.D. in Statistics/Biostatistics with demonstrated 2+ years (for M.S.) or 0-1 year (for Ph.D.) of statistical consulting experience, preferably in biopharmaceutical development. Other field of studies with demonstrated extensive training in statistics may also be considered.
• Experience with advanced statistical concepts such as Analysis of Variance (ANOVA) / Analysis of Covariance (ANCOVA), Design of Experiment (DOE), Response Surface Methodology (RSM), Equivalence Testing, Variance Components Analysis (VCA), Mixed Models.
• Fluency in SAS, JMP, and R statistical software packages
• Ability to interact with process development engineers, analytical chemists/biologists, quality, and regulatory colleagues to understand business problem that requires statistical support.
• Excellent verbal/written communication skills to convey statistical analyses via oral presentation and formal written reports to audience/readers that may have varying backgrounds in statistics.
• Familiarity with regulatory and industry guidelines (ICH, FDA, EMA) applicable to biopharmaceutical drug development and manufacturing (preferred).
• Understanding of biologic product development, bioanalytical methods, and cGMP biologic manufacturing (preferred).
Ability to perform complex quantitative analyses used for technical problem-solving and decision-making.
Requires prolonged seating/standing in office desk.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
May require minimal 10-15% travel to other sites.
May require calling in outside of regular North America business hours to other the company locations outside of the US with different time zones.
Other Information - Internal
Colleagues who are issued any type of progressive disciplinary action on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date disciplinary action is issued.
Legacy Hospira grade 15
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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