Principal Statistical Programmer (ADaM, TLFs, SDTM)
Position Overview
This role is an advanced-level position within Syneos Health's Statistical Programming team, where you will leverage your expertise to contribute to the programming and analysis of clinical trial data. The Principal Statistical Programmer plays a crucial part in generating analysis-ready datasets (ADaM), tables, listings, figures (TLFs), and standard datasets (SDTM) that adhere to regulatory and industry standards.
Key Responsibilities
Programming and Analysis:
Develop and validate SDTM, ADaM datasets, and TLFs using SAS or other statistical software.
Ensure all deliverables align with CDISC (SDTM/ADaM) and project-specific requirements.
Quality and Compliance:
Maintain programming deliverables in compliance with industry standards (GCP, regulatory guidelines) and Syneos Health's SOPs.
Perform quality checks and ensure consistency across programming outputs.
Collaboration:
Partner with cross-functional teams, including biostatistics, clinical operations, and data management, to understand project requirements and timelines.
Act as a programming lead on assigned projects, managing timelines and deliverables.
Training and Mentorship:
Provide guidance and technical support to junior programmers.
Share best practices and solutions to enhance team efficiency.
Documentation:
Create detailed documentation for all programming tasks, ensuring reproducibility and traceability.
Respond to audit and regulatory inquiries as needed.
Qualifications
Educational Background:
Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, or a related field.
Professional Experience:
Extensive experience (typically 7+ years) in statistical programming within a CRO, pharmaceutical, or biotechnology setting.
Expertise in SDTM, ADaM, and TLF programming.
Technical Skills:
Proficiency in SAS and other statistical software.
Strong understanding of CDISC standards and FDA/EMA regulatory requirements.
Soft Skills:
Excellent problem-solving skills and attention to detail.
Effective communication and ability to present complex information clearly to non-technical stakeholders.
Additional Requirements:
Ability to work independently in a home-based or remote environment.
Willingness to manage multiple priorities and adapt to changing project needs.
Why Join Syneos Health?
Work on cutting-edge therapies in a dynamic and collaborative environment.
Be part of a team that contributes to 94% of all novel FDA-approved drugs over the last 5 years.
Enjoy professional development opportunities, including technical training and mentorship programs.
Embrace the company’s Total Self Culture, promoting diversity, equity, and inclusion.
Location: India (Home-Based)
Updated: December 3, 2024
Job ID: 24006553
Apply Now to bring your expertise in statistical programming to a role that directly impacts patient lives worldwide.
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