Senior Scientist, Biostatistics, CMC Statistics

** Job Description*
* In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

This job description outlines the responsibilities, primary activities, educational requirements, and skills needed for a biostatistical leadership role in drug development, particularly within the Chemistry, Manufacturing, and Controls (CMC) Statistics area in biologics.

** Responsibilities*
* The role involves providing biostatistical leadership and support for drug development projects in CMC area, coordinating with various internal groups such as analytical, formulation, project management, regulatory, statistical programming, data management, and manufacturing divisions. The individual serves as a statistical lead in project teams, managing multiple projects independently and supporting scientific protocols. They represent the statistical function in cross-functional teams and contribute to department and therapeutic area goals.

Participation in professional societies and technical associations is also expected.

** Primary Activities*
* Key activities include acting as the statistical representative and lead in cross-functional teams for strategic planning and product development execution. The role requires developing data analysis plans and selecting appropriate statistical methodologies to analyze and interpret data from CMC-related studies. Preparing reports to communicate results to project teams, management, regulatory agencies, or scientists is essential. Additionally, mentoring junior staff is part of the responsibilities.

** Education and Minimum Requirement*
* Candidates should hold a PhD or equivalent degree in statistics, biostatistics, or a related field. Alternatively, a Master's degree in Statistics or Applied Statistics with at least three years of relevant experience is acceptable.

** Required Skills and Experience*
* The role demands knowledge of statistical analysis methodologies and experimental design, including mixed models, variance component analysis, equivalency studies, nonlinear regression, and Bayesian analysis. Proficiency in statistical software such as JMP, SAS, and/or R is required. The individual should demonstrate the ability to learn proactively, be motivated, detail-oriented, and capable of working independently. Strong communication skills and effective collaboration across functions are also necessary.

** Preferred Skills and Experience*
* An understanding of disease biology and drug discovery and development is preferred for this position.

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* Required Skills:

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* Biostatistics, Collaborative Communications, Data Analysis, Data Management, Data Science, Detail-Oriented, Numerical Analysis, Pharmaceutical Development, Scientific Modeling

** Preferred

Skills:

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* Current Employees apply HERE ($6687.htmld)

Current Contingent Workers apply HERE ($4020.htmld)

** US and Puerto Rico Residents Only:*
* Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  ()  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  

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The salary range for this role is

$ - $

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant…