Senior Scientist – Statistical Process Control, Data Analytics

SOKOL GxP Services

. Prepare, clean, merge, and analyze manufacturing and quality datasets using R and statistical analysis tools .

Posted 10/23/2026contractMadison • New Jersey • United StatesSenior💰 $116,064 - $126,464 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical analysis and data management within a GMP-regulated environment, utilizing R and other statistical tools for process monitoring and reporting. Strong ability to collaborate with cross-functional teams and communicate technical findings effectively.

Highest-signal resume keywords

Statistical Process Control (SPC)Data Analysis Using RGMP-Regulated Environment ExperienceContinued Process Verification (CPV)Technical Writing Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisData PreparationMultivariate AnalysisProcess Capability AnalysisData ManagementStatistical Process Control (SPC)Automation of Reporting SystemsApplied Coding ExperiencePython AutomationLean Six Sigma Methodologies

Soft Skills

Strong Communication SkillsCross-Functional Stakeholder ManagementTechnical Writing SkillsMatrix Team CollaborationProject Management

Tools & Technologies

RJMPPythonStatistical Analysis ToolsAnalytical Systems

Industry Keywords

Pharmaceutical ExperienceGMP ComplianceManufacturing Data AnalysisQuality Data AnalysisCell Therapy Manufacturing

Tech Stack

Tools & technologies

Python

About the role

Key responsibilities & impact

Prepare, clean, merge, and analyze manufacturing and quality datasets using R and statistical analysis tools
Perform statistical process control, process capability analysis, and multivariate analysis
Monitor CPV parameters, identify process trends and drifts, and evaluate statistical alerts
Support CPV/APQR reporting, investigations, and root cause analysis
Configure analytical systems and support automation of data preparation and reporting
Prepare technical reports and GMP documentation
Collaborate with Manufacturing, Quality, MSAT, Engineering, and other cross-functional stakeholders
Work on an initial 6-month contract with potential extensions up to 2 years based on performance and client needs
Work 50% onsite in Madison, New Jersey, with flexible onsite days
Work Monday–Friday, 9 AM–5 PM EST, 40 hours per week
Travel globally up to 10%

Requirements

What you’ll need

Bachelor's degree in Life Sciences, Biotechnology, Engineering, Statistics, Data Science, or a related discipline
5+ years of pharmaceutical experience in a GMP-regulated environment
3+ years of experience in data management and analytics
Strong hands-on experience with R for data preparation, manipulation, and analysis
Strong working knowledge of statistical analysis using JMP, R, or Python
Experience with statistical process control (SPC), process monitoring, and capability analysis
Applied coding experience supporting data analytics, reporting, or process monitoring
Ability to analyze manufacturing or quality datasets, identify trends, and communicate findings
Strong communication, technical writing, and cross-functional stakeholder management skills
Ability to work effectively within a matrix team
Experience supporting SPC for commercial cell therapy manufacturing (preferred)
Experience with Continued Process Verification (CPV) and Annual Product Quality Review (APQR) (preferred)
Experience with multivariate analysis and process engineering (preferred)
Experience configuring or automating statistical monitoring and reporting systems (preferred)
Python automation experience (preferred)
Experience leading meetings and managing small projects (preferred)
Experience with Lean Six Sigma or Operational Excellence methodologies (preferred)
Must be able to work in the United States; no visa sponsorship

Benefits

Comp & perks

Health insurance with dental and vision insurance options.
Holiday pay.
401(k) program.
Employee referral bonus program.
The client retains the right to hire the contractor directly.