Sr. Statistician, R&D
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The R&D Biostatistician/Sr. Biostatistician is responsible for providing biostats support to a broad range of R&D internal customers. This will include experimental design planning, data analysis of experimental results, generating statistical reports, etc.
I. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Provide statistical support to R&D scientists across the organization to ensure efficient and effective design of R&D studies to support objectives and in the preparation of statistical sections of study protocols/reports.
• Preparation and validation of JMP/SAS (or similar) programs for the analysis and reporting of data from various R&D studies.
• Communication of statistical analysis to regulatory authorities when required
• Biopharma Industry Statistical analysis in the following (but not limited) to areas:
o ICH Process and analytical method validation, tech transfer, comparability assessment (TOST)
o DOE/Mixture design for process/product optimization
o USP Biological assay (parallel-line analysis)
o ICH Stability data analysis
o Bioanalytical, biomarker, anti-drug antibody assay qualification/validation data analysis
• Provide statistical consultation and data analysis support as required to departments outside R&D (e.g., Clinical Research, Manufacturing, Quality, etc.).
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• PhD (2-5yrs), or a minimum of a master’s degree (3-5+yrs) with specialization in Statistics.
• Knowledge of statistical theory and application of statistical methodologies in study design and data analysis is required.
• Analysis of data using linear mixed models, generalized linear mixed models, survival, and categorical methods
• Experience in the pharmaceutical industry or industrial engineering/statistical process control
• Strong working knowledge of experimental design and analysis of data for scientific applications including statistics, distribution analysis, manufacturing capability assessment statistical process control (Six sigma, Cpk, setting specifications, etc.), Design of experiments (DOE), variation analysis, comparison tests, sample size selection, hypothesis testing, confidence intervals and multiple factor variance modeling is considered an asset.
• Experience with SAS, R, SQL, JMP, GraphPad Prism, MS-Excel, MS-Access and MS-Word, as well as knowledge of regression analysis, ANOVA, sampling techniques, categorical data analysis, and exploratory data analysis.
• Must possess excellent organizational, analytical, and problem-solving skills, as well as excellent written, verbal, and interpersonal skills as well as ability to work as part of a team.
Preference is to be on site working directly with Scientists, but part-time or full-time remote work arrangements will be considered for very strong candidates.
Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment, subject to legally required exemptions.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.