Job Description
Job Name: Statistician 341770
Location : New Brunswick NJ 08903
Contractor Work Model: 50% hybrid required
Work Schedule : Mon- Friday (normal business hours)
Term : 1-yr contract
Pay Rate: Up to $60/hr (dependent on experience)
Top Skills/Must Haves: - Required Minimum MS (with 2+ years of experience) or PhD (with no additional experience) in Statistics, Biostatistics, Applied Mathematics, or other related fields.
- 3+ years of experience in applying statistical methodologies such as Linear regression, Analysis of variance (ANOVA), Design of Experiments (DoE), Mixed models, and Multivariate Analysis to real datasets. Must include direct experience with CMC specific statistical methodologies and regulatory requirements.
- 3+ years of experience in one or more statistical software (e.g., JMP, SAS, R, or Python).
- 1+ years of data analysis experience in the Biopharma space.
- Strong communication skills and the ability to explain statistical techniques to non-statisticians
Job summary: This position is responsible for providing statistical analysis, direction, and training to service clients in Global Product Development & Supply (GPS) to ensure robust processes and methods, thereby delivering product quality and compliance. Areas of support include development, process improvement, tech transfer, validation, PAIs, clinical supplies, manufacturing, transportation, health authority filings, and regulatory responses. Support and guidance in relation to study design and data analysis are provided worldwide to the COMPANY facilities.
Major Duties and Responsibilities: - Support the GPS network stakeholders globally to understand their statistical needs and determine sound statistical techniques for use.
- Collaborate with Manufacturing, Manufacturing Science &Technology, and process analytics teams to design studies and analyze complex datasets, driving process robustness and improvement.
- Support Quality Control and Analytical Sciences & Technology teams in method lifecycle management and reference standard qualification, including development, validation, and investigations.
- Develop and implement statistical approaches for study design and data analysis to ensure batch compliance and reduce risks of rejection or recall. This may include Specification setting, Process Capability, Sampling plans, and product shelf life (expiry/retest periods).
- Perform thorough statistical analyses, provide data-driven insights, and recommend actionable solutions aligned with business needs.
- Demonstrates strong statistical expertise while thinking in a clear, conclusive manner. Reaches independent, logical solutions.
- Represent Global Statistics at Product Development, product protocol, and management meetings.
- Contributes to improvement and standardization of processes, procedures, and systems in relation to Statistics while maintaining flexibility where required.
- Furthers the statistical awareness and statistical process control competency of other COMPANY personnel; participates in their training and development, as needed.
- Enhance statistical awareness across the organization by supporting training and development in statistical methods and process control.
- Foster a shared commitment to quality and compliance at every level.
- Model and reinforce COMPANY BioPharma Behaviors in daily responsibilities.
Minimum Qualifications: - Required MS (with 2+ years of experience) or PhD (with no additional experience) in Statistics, Biostatistics, Applied Mathematics, or other related fields.
- Mastery of statistical methods such as Design of Experiments (DoE), Analysis of Variance (ANOVA), Mixed models, and Multivariate Analysis.
- Advanced skills using one or more statistical software (e.g., JMP, SAS, R, or Python).
- Ability to analyze and interpret scenarios, and through effective study design and statistical analysis, provide answers and appropriate courses of action.
- Capable of managing multiple projects in a dynamic environment.
- Strong communication skills and the ability to explain statistical techniques to non-statisticians.
Preferred Requirements (Bonus points if you have): - Biopharmaceutical development and manufacturing experience, with a strong preference for CMC statistics background.
- Familiarity with FDA, EMA, and other global regulatory compliance guidelines (e.g., ICH guidelines) related to drug manufacturing, packaging, and distribution.
- Knowledge of Statistical process control, Variance component analysis, and Bayesian methodology.
Ref: #568-Clinical
Job Tags
Contract work, For contractors, Worldwide,