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Job Details

Skills

SAS
Project Management
Team Leadership
Statistics
SAP
Attention To Detail
Auditing
CDISC
Clinical Research
Collaboration
Data Analysis
Data Visualization
Documentation
Effective Communication
Emerging Technologies
Immunology
Macros
Jersey
Mentorship
Neuroscience
Programming Languages
Publications
Quality Control
Regulatory Compliance
R

Summary

Role: Senior Statistical Analyst - Full-time

Location: Cincinnati, OH or Chicago, IL or New York City, NY or New Jersey

10 - 23 years of experience

Must Have Technical/Functional Skills

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.
Advanced knowledge of CDISC standards and therapeutic areas (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 the requirement.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10217521
Position Id: 421884/-HE
Posted 5 days ago

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Brazil Dsouza

Technical Recruiter @ Ztek Consulting

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