Do you possess a PhD with 8 years of experience, or MS and 10 years of experience in Biostatistics? Do you have experience in providing scientific and technical evaluations of assay performance?
Description of ideal candidate:
- Industry experience in support of a chemical medicines compendia or product development and quality environment is desirable. Experience with reference materials development is a plus.
- Experience with pharmaceutical and biotechnology product development.
- Experience in development and evaluation of analytical methods for the characterization of biopharmaceutical products, specifically the statistical analysis aspects.
- Experience with the development and analysis of study protocols for reference materials
- Statistical design and analysis of bioassay studies
- Experience with the statistical aspects of validation
- Understanding of pharmaceutical quality systems and associated regulatory framework is essential (ICH guidelines and FDA’s IND, NDA, BLA)
- Ability to write technical reports pertaining to the evaluation of materials testing and methods development.
- Able to establish and nurture relationships with individuals of varying backgrounds and learning styles. Able to operate independently where appropriate, yet understands when to escalate issues and how to establish effective working relationships.
- Excellent writing, interpersonal and communication skills (written and oral).
- Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.
- Knowledge of internet, electronic database searches, and statistical software industry.
- Project Management skills. Must have ability to prioritize and manage multiple, concurrent projects with often long life cycles.
- Must be able to share technical information with non-technical or non-scientific staff, and to communicate effectively with representatives from pharmaceutical companies, government, and academic institutions. Ability to persuade corporations to collaborate with organization on various projects.
- Experience with, and knowledge of the USP-NF is preferred.
Oversees and facilitates all aspects of the development of General Chapters to the USP-NF, from development of the initial proposal to the publication of the documentary standard. Evaluates and analyzes supporting data, and translates into editorial style and format
.• Acts as an internal expert in statistical analyses and work closely with scientists and expert committees, and provides day to day support for study design, sampling strategies and data analysis to facilitate the development of candidate’s reference materials into Reference Standards.
• Manages the activities of Statistics Expert Committee, including work plan development and management, interface with the Chair and coordinating point for all of the EC’s scientific activities.• Supports the design and execution of collaborative testing, once a candidate material has been sourced. Prepares statistical analysis summary to accompany the reference standard candidate evaluation packages.
• Evaluates on a regular basis the need to develop new guidance on data analysis, and monitors the interdependencies between monographs and chapters and helps create consistency in statistical approaches.
• Provides scientifically and technically sound evaluation of assay performance; helps with assay troubleshooting, as well as the review and approval of data generated by laboratory scientists.• Writes general and specific subject correspondence pertaining to monographs, general chapters, reference materials, and various policy issues. Plans and oversees necessary laboratory work for method development and verification as needed
.• Communicates and maintains working relationships with other departments regarding projects related to validation studies, methods development, reference standards, and other cross-cutting activities. • Keeps abreast of current trends and developments in related scientific fields, particularly in the area of statistical analysis for assays included in USP monographs and chapters. • Responds to stakeholder inquiries pertaining to USP-NF monographs, reference standards and General Chapters (as assigned).
• Serves as representative of organization at professional meetings (scientific meetings organized by USP and other organizations, meetings at other pharmacopeias or regulatory agencies etc.). Minimum Requirements:Ph.D. degree in Statistics or Biostatistics with eight (8) years of relevant experience or M.S. and ten (10) years.
Must be a US citizen or Green Card Holder. e-mail resume to email@example.com