Principal Stat Programmer

Syneos Health

2+ years

Not Disclosed

India

10 Dec. 1, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

The Principal Statistical Programmer position at Syneos Health outlines a leadership role for a highly skilled individual in clinical trial programming. Below is a summary of the key aspects:

Position Overview

Location: Home-Based, India-Asia Pacific
Updated: November 25, 2024
Job ID: 24006303

As a Principal Statistical Programmer, you will lead programming activities, oversee multiple projects, and ensure high-quality statistical analysis in clinical trials. Your role will focus on using software like SAS to generate datasets, tables, graphs, and validate programming outputs. You will serve as a technical resource, guiding and mentoring team members while ensuring compliance with regulatory standards.

Key Responsibilities

Programming & Quality Control:
- Develop and execute programming tasks using SAS or other software to generate datasets, summary tables, listings, and graphs based on statistical analysis plans.
- Ensure high-quality outputs meet project and regulatory requirements, managing discrepancies with other team members as necessary.
Project Management & Coordination:
- Manage multiple projects, ensure on-time delivery, and adapt to changes in timelines or priorities.
- Oversee and coordinate programming deliverables across teams, providing risk mitigation plans when needed.
Leadership & Mentorship:
- Lead programming efforts, directing other team members, and mentoring junior staff.
- Participate in training courses, provide feedback, and review work to ensure high standards in the clinical trial process.
Regulatory Compliance & CDISC Standards:
- Act as a subject matter expert for CDISC and industry regulatory standards, conducting compliance reviews for SDTM and ADaM datasets, and related regulatory documents.
- Provide training and guidance on CDISC standards to the Biostatistics group and other departments.
Collaboration & Stakeholder Communication:
- Serve as the statistical programming representative in sponsor meetings and bid defense meetings.
- Contribute to the development of programming tools and macros to increase efficiency and standardization.
Documentation & Reporting:
- Maintain well-organized project documentation and ensure readiness for inspections.
- Provide feedback to ensure project documentation, including Statistical Analysis Plans and programming specifications, meets quality standards.

Qualifications

Education:
- Undergraduate degree, preferably in scientific or statistical disciplines, or equivalent programming experience.
Experience:
- Extensive experience in SAS programming, ideally within a clinical trial environment.
- Strong knowledge of CDISC Standards for regulatory submissions.
- Experience leading complex and global programming projects and mentoring team members.
Skills:
- Excellent written and verbal communication skills in English.
- Ability to manage multiple projects, solve complex issues, and communicate effectively across teams.
Preferred:
- Experience in submissions to regulatory agencies is preferred.

Why Syneos Health?

Innovative and Collaborative Environment:
- Collaborate on projects that contribute to 94% of FDA-approved drugs in the last five years.
- Work in a diverse, inclusive, and innovative culture focused on continuous improvement and development.

Application Information

If you meet the qualifications, you are encouraged to apply directly. Syneos Health values transferable skills, diversity, and inclusion in its hiring process. To stay connected for future opportunities, consider joining their Talent Network.

For further details or to apply, click here.

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