Statistician

Overview

On Site
USD 59.00 - 60.00 per hour
Contract - W2

Skills

Pharmaceutics
Recruiting
SAP BASIS
Training
Process Improvement
Biostatistics
Applied Mathematics
Design Of Experiments
Analysis Of Variance
Multivariate Analysis
JMP
SAS
R
Python
Communication
Crystal Management Console
Distribution
Global Positioning System
Network
Collaboration
Manufacturing
Analytics
Quality Control
Analytical Skill
Science
Lifecycle Management
Data Analysis
Product Development
Management
Statistics
Statistical Process Control
Training And Development
Process Control
Regulatory Compliance

Job Details

Our client, a leading pharmaceutical company, is hiring a Statistician, on a contract basis.

Job ID: 83507

Work Location:
New Brunswick, NJ - 50% on site

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 facilities.

Education/Experience:
  • 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:
  • 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.

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 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 BioPharma Behaviors in daily responsibilities.

Pay: $59-$60/hr
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