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Senior Statistical Analyst

K&K Global Talent Solutions Inc.

Cincinnati, OH

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JOB DETAILS
SALARY
$120,000–$140,000
SKILLS
Analysis Skills, Best Practices, Clinical Data Interchange Standards Consortium (CDISC), Clinical Research, Clinical Trial, Coaching, Communication Skills, Cross-Functional, Data Analysis, Data Visualization, Detail Oriented, Documentation, Emerging Technology, Identify Issues, Immunology, Leadership, Maintain Compliance, Mentoring, Neuroscience, Oncology, Presentation/Verbal Skills, Problem Solving Skills, Program Planning, Programming Tools, Project Tracking, Publications, R Programming Language, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Risk, SAP, Software Engineering, Standards Development, Statements on Auditing Standards (SAS), Statistical Analysis System (SAS), Statistical Programming Languages, Statistical Quality Control, Statistics, Statistics Software, Team Lead/Manager, Team Player, Time Management, Validation Plan, Writing Skills
LOCATION
Cincinnati, OH
POSTED
1 day ago

Job Title: Senior Statistical Analyst

Location: Chicago Ridge, IL (Onsite)

Job Type: Full Time

Required Skillsets:

  • Proficiency in SAS / R programming languages to Program and validate ADaM, TFL and statistical analyses
  • Proficiency in using statistical software and programming tools
  • Understanding of statistical methods, data analysis techniques, and clinical research processes.
  • Advance knowledge of CDISC standards and therapeutic area (Oncology, Immunology, Neuroscience etc.)
  • Strong attention to detail and quality Focus
  • Problem-solving skills (Ability to identify and troubleshoot programming issues)
  • Effective communication skills (both written and verbal)
  • Ability to interact professionally with statisticians, study teams, and external partners
  • Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines.

Key Responsibilities:

  • Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP). Implement Statistical Analysis Plans (SAP) and SPP to create ADaM data specifications.
  • Program and validate ADaM and statistical analyses using programming languages (e.g., SAS, R), ensuring adherence to established standards and guidelines.
  • Generate tables, listings, and figures (TLFs) for clinical study reports, safety reports, and other deliverables, ensuring accuracy, consistency, and adherence to regulatory requirements.
  • Develop and maintain programming documentation, such as annotated program code, programming specifications, and validation plans.
  • Perform quality control checks on statistical programming deliverables to ensure accuracy, consistency, and adherence to programming standards.
  • Collaborate with cross-functional teams to support ad hoc data analyses, data visualization, and exploratory analyses as needed.
  • Ability to lead the development and implementation of standard programming macros, utilities, and tools to improve efficiency and consistency in programming tasks.
  • Stay updated with industry best practices, regulatory guidelines, and emerging technologies in statistical programming and data analysis.
  • Lead the planning and execution of statistical programming-related audits, inspections, and regulatory submissions, ensuring compliance with relevant regulations and guidelines.
  • Collaborate with statisticians and study teams to provide programming support, address data-related queries, and contribute to study-related publications.
  • Performs assigned task(s) in accordance with customer requirements within agreed timelines and Quality.
  • Escalates unresolved issues appropriately to Team Lead /Project Lead. Tracks and follows up on all issues raised. Provides timely status updates. Proactively highlight risk.
  • Coach/Mentor/Train new team members and line function as per requirement.

About the Company

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K&K Global Talent Solutions Inc.