Bioanalytical Drug Development Statistician – Immunogenicity Support
This position will provide the opportunity to work in a small, rapidly growing company who is focused in R&D for biotech drug development. Individual will be a member of a team which provides professional statistical consulting services to support external clients.
This position will primarily emphasize conducting statistical analyses to support the establishment of immunogenicity cut points for the detection and characterization of anti-drug antibodies. Position also includes statistical support of biomarker, assay development and CM&C projects as needed.
Duties and Responsibilities
- Consult with clients to develop statistical strategies to support biotech R&D
- Work within a team setting to participate in the development of statistical methodology to support client projects and advance company capabilities
- Collaborate with clients on early study design, data analysis and interpretation of results
- Use existing statistical software and a variety of established statistical methods to gather, analyze, and interpret data to derive useful information for research studies
- Format data, develop and prepare reports, charts, tables, and other related documents and graphics
- Keep up to date with new publications and methodologies used in immunogenicity, biomarker, CM&C, and pharmacokinetic statistical analysis
- Supervise personnel and/or students on specific, project-related tasks
- Perform miscellaneous job-related duties as assigned
- Open to considering remote location for candidates with experience working with a distributed team
Education and Experience:
- Ph.D. or M.S in statistics preferred; B.S. in statistics may be considered with appropriate work experience
- At least 1 year of experience directly related to the duties and responsibilities specified, but will consider a talented and energetic individual with other biotech or pharmaceutical experience
Knowledge, Skills, and Abilities:
- Experience with statistical analysis software (R, SAS, etc.)
- Ability to communicate effectively with non-statisticians, both orally and in writing
- Must be able to work in a team setting that includes senior scientists, medical writers, QC/QA, project managers, and scientific staff
- Knowledge of statistical research principles, methods, procedures, and standards
- Ability to analyze and interpret statistical data
- Knowledge of experimental design, statistical sampling, and survey methodology
- Ability to format data to develop and prepare reports, charts, tables, and other related documents
- Individual must be self-motivated and have initiative to undertake client projects
- Competent in using standard MS office programs
- Experience in pharmaceutical development is desired.
Must be able to work in the US.