Summary of the Position:
The Statistics Sr/Manager leads the CMC Statistics team, which is one of the primary groups within the CMC Data and Advanced Analytics COE. This position supports the statistical needs of nonclinical groups through managing the CMC Statistics team's day to day work and tactical projects, while ensuring the COE's strategic goals are achieved. This is a remote position.
Responsibilities include but are not limited to:
- Manage our team of CMC statisticians, lead and coordinate statistical efforts throughout CMC.
- Provide sound strategic, scientific, and statistical input to our CMC Statistics team in support of the ongoing and the future work in nonclinical research and development projects, through their work in
- design of experiments and by using appropriate statistical methodology and sample size.
- preparation of statistical analysis plans; analysis of experimental and historical data.
- Creating design of experiments and performing various types of statistical analyses to develop predictive models and optimize conditions for processes, methods, and drug product/drug substance storage.
- performing stability analysis to identify degradation rates and expiration dates.
- Preparing the statistical section of technical reports and presentations.
- Engaging in discussions and research to ensure the central place of applied statistics in research, development, quality, and validation projects.
- Ensure multiple projects are managed effectively to meet internal customers' deadlines with high quality of standards.
- Explain statistical designs and concepts to internal customers
- Responsible for ensuring the administrative tasks for the CMC Statistics team are completed in a timely manner.
Minimum requirements:
- A degree in Statistics/Biostatistics, Bioengineering, Chemical Engineering, or a related field
- For the Manager level, BS degree with 9+ years of industry or Master's degree with 6+ years of industry experience or PhD degree with 4+ years of industry
- For the Sr Manager level, BS degree with 12+ years of industry or Master's degree with 9+ years of industry experience or PhD degree with 7+ years of industry
- Previous experience in managing a team of CMC Statisticians
- Sound knowledge of theoretical and applied statistics is required, preferably with an emphasis on experimental design in biotechnology, statistical process control, analytical method development, process characterization, formulation development, stability, power calculations, etc.
- The candidate should have hands-on experience with using and scripting statistical software packages including JMP.
- Familiarity with ICH guidelines.
- Experience in the drug development field is preferred.
- Must be an effective and proactive leader, team player, able to thrive in a fast-paced team environment, and also work independently on projects.
- Excellent interpersonal, oral, and written communication skills.
- Mentorship ability to influence team members and communicate statistical concepts across functions.
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