Sr. Statistician, CMC

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.

Education and Minimum Requirement:

• Master's degree in statistics or related discipline with a minimum of 3 years relevant experience.

• A minimum of 12 months' experience in large molecule drug substance process characterization.

 

Required Skills and Experience:

• This is a hands-on project facing position and must have demonstrated experience interacting with large molecule drug substance process characterization teams.

• Must have demonstrated experience of effectively working remotely; Must be able to travel to Rahway site as business needs dictate.

• Proven experience applying DOE to real-life large molecule drug substance process characterization problems.

• Proven experience with large molecule drug substance process characterization study data management in structured database (e.g., RLIMS)

• Proven experience of statistical analysis methodologies for mixed-effects models, including variable selection, and experimental design.

• Proven experience generating simulations for PAR setting, generating impact ratios and other details for parameter classification.

• Strong hands-on experience with JMP and working knowledge of other statistical and data processing software.

• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

• Strong oral and written communication skills. Able to function effectively in a fast paced, team environment. Flexibility is critical.

 

Responsibilities:

• Willing to learn and use the internal computing platform.

• Develop study design (DOE), statistical analysis, and reported output using in-house developed JMP tools in fast-paced, critical path projects.

• Provide expert second statistician review of drug substance process characterization studies.

• Participate on drug substance process characterization teams to understand requirements to design study experiments and discuss results. Experiment design entails having joint conversations with the Process scientists/engineers to discuss the issues and constraints on study design and execution.

• Work with Process Scientists/Engineers to complete study reports as needed.

BARDS2020

#eligibleforERP

Required Skills:

Biostatistics, Communication, Data Analysis, Data Management, Data Science, Design of Experiments (DOE), Oral Communications, Process Characterization, Process Consulting, Process Research, Remote Workforce, SAS JMP (Statistical Software), Scientific Modeling, Scientific Study Design, Statistical Analysis, Statistical Design of Experiments (DOE), Statistics, Written Communication

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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 click here 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.  For more information about person