Principal Scientist, Biostatistics

Jobtailor; Raritan, Northern (NJ, KY); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Jobtailor in the United States (New Jersey) seeks an experienced statistician to drive design of studies across Clinical Development, Medical Affairs, and Manufacturing Sciences. You will support data analysis, interpretation, and reporting while collaborating with cross-functional drug development teams to advance regulatory commitments.

The role requires leadership in study design and the application of advanced statistical techniques, with proficiency in SAS, R, and Python.

Qualifications

• Minimum Master’s degree with 6+ years of relevant experience, or PhD with 4+ years of relevant experience.
• Proficiency in SAS, R programming, or other relevant computational tools such as East Horizon, RPACT, FACTS, or Python.
• Full proficiency in R and SAS.
• Familiarity with innovative data-adaptive methods and artificial intelligence.
• Excellent interpersonal, verbal, and written communication skills.
• Demonstrated ability to work in interdisciplinary contexts outside statistics.

Responsibilities

• Provide input to the design and execution of studies and experiments for Clinical Development, Medical Affairs, Discovery, and Manufacturing Sciences programs.
• Support statistical analysis, interpretation, reporting, and communication of data evidence.
• Collaborate with Quantitative Sciences & Clinical Pharmacology and other drug development scientists.
• Support statistical aspects of business and regulatory commitments.
• Contribute to program plans and represent Statistics & Decision Sciences in teams and working groups.
• Apply advanced data analytics and high-quality statistical methodologies.
• Optimize study designs, conduct scenario simulations, and perform sample size calculations.
• Identify and implement advanced statistical techniques for complex projects.
• Provide leadership and guidance on study and trial design.
• Collaborate cross-functionally to identify and resolve issues.
• Participate in process improvement and standards development.
• Build partnerships with internal colleagues, CROs, consultants, and other external partners.
• Deliver high-quality, timely outputs to project teams, clinical trial teams, and the Statistics Area Head.
• Track external scientific and statistical trends and advance methodologies through scholarly publications.
• Participate in interactions with health authorities.

Skills

SAS Programming

R Programming

Python

East Horizon

RPACT

FACTS

Education

Master's degree with 6+ years of relevant experience

PhD with 4+ years of relevant experience

Tools

SAS

R

East Horizon

RPACT

FACTS

Python

Job description

• Provide input to the design and execution of studies and experiments for Clinical Development, Medical Affairs, Discovery, and Manufacturing Sciences programs
• Support statistical analysis, interpretation, reporting, and communication of data evidence
• Collaborate with Quantitative Sciences & Clinical Pharmacology and other drug development scientists
• Support statistical aspects of business and regulatory commitments
• Contribute to program plans and represent Statistics & Decision Sciences in teams and working groups
• Apply advanced data analytics and high-quality statistical methodologies
• Optimize study designs, conduct scenario simulations, and perform sample size calculations
• Identify and implement advanced statistical techniques for complex projects
• Provide leadership and guidance on study and trial design
• Collaborate cross-functionally to identify and resolve issues
• Participate in process improvement and standards development
• Build partnerships with internal colleagues, CROs, consultants, and other external partners
• Deliver high-quality, timely outputs to project teams, clinical trial teams, and the Statistics Area Head
• Track external scientific and statistical trends and advance methodologies through scholarly publications
• Participate in interactions with health authorities

Requirements

• Minimum Master's degree with 6+ years of relevant experience, or PhD with 4+ years of relevant experience
• Proficiency in SAS, R programming, or other relevant computational tools such as East Horizon, RPACT, FACTS, or Python
• Full proficiency in R and SAS
• Familiarity with innovative data-adaptive methods and artificial intelligence
• Excellent interpersonal, verbal, and written communication skills
• Demonstrated ability to work in interdisciplinary contexts outside statistics

Core Competencies

Demonstrates expertise in statistical analysis, advanced data analytics, and study design within clinical development and regulatory environments. Proficient in SAS and R programming, with a strong ability to collaborate cross-functionally and communicate complex data insights effectively.

Highest-signal resume keywords

• Statistical Analysis
• SAS Programming
• R Programming
• Study Design Optimization
• Interdisciplinary Collaboration

Hard Skills

• Statistical Methodologies
• Data Analytics
• Sample Size Calculations
• Scenario Simulations
• Advanced Statistical Techniques

Soft Skills

• Interpersonal Communication
• Verbal Communication
• Written Communication

Industry Keywords

• Clinical Development
• Medical Affairs
• Regulatory Commitments
• Process Improvement
• Health Authorities

Tools & Technologies

• SAS
• R
• East Horizon
• RPACT
• FACTS
• Python