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 involves leading and managing statistical programming activities, including working with SAS and other software to generate summary tables, listings, graphs, and derived datasets based on statistical analysis plans. You will also be responsible for ensuring that programming outputs meet project quality standards and regulatory requirements.

Position Overview

Location: Home-Based, India-Asia Pacific
Updated: November 12, 2024
Job ID: 24006090

This role focuses on providing leadership in statistical programming, ensuring the quality and timely delivery of programming deliverables, and mentoring junior team members. It also involves contributing technical expertise on industry standards, especially CDISC, and guiding the team through complex programming challenges.

Key Responsibilities

Statistical Programming and Analysis:
- Use SAS (and other software) to develop custom programming code to generate outputs like tables, listings, graphs, and datasets according to specifications.
- Validate programming and collaborate with other programmers and biostatisticians to resolve discrepancies or issues.
Project Management:
- Oversee programming deliverables across multiple projects, manage timelines, and address potential risks.
- Ensure that all project documentation is well-organized and up-to-date, maintaining inspection readiness at all times.
Leadership and Mentorship:
- Lead programming activities and manage teams of statistical programmers to ensure the timely delivery of results.
- Mentor junior programming staff by developing training materials, reviewing their work, and offering guidance.
Regulatory and CDISC Expertise:
- Provide subject matter expertise on CDISC standards and regulatory requirements, including SDTM and ADaM specifications.
- Participate in industry standards organizations and provide regular updates to the team on changes to standards.
Collaboration and Communication:
- Contribute to sponsor meetings, bid defense meetings, and project reviews, ensuring clear communication with all stakeholders.
- Act as the programming representative in project meetings, helping resolve issues and discussing programming challenges.

Qualifications

Education: Undergraduate degree in a scientific or statistical discipline, or an equivalent combination of education and demonstrated programming experience.
Experience:
- Extensive programming experience in SAS (or similar software), particularly in the context of clinical trials.
- Strong knowledge and experience with CDISC standards, especially for regulatory submissions.
- Experience in mentoring and leading programming teams.
Skills:
- Excellent communication skills (written and verbal) in English.
- Ability to work independently and manage multiple priorities effectively.
- Knowledge of regulatory agency submission requirements and industry standards.

Why Syneos Health?

Culture:
Syneos Health fosters a Total Self culture, where employees can authentically be themselves. It offers career development, technical training, and a focus on inclusion and diversity.
Benefits:
Competitive benefits including health plans, stock purchase options, and career development opportunities.

Application Information

If you have extensive experience in SAS programming and CDISC standards, and you’re looking to take on a leadership role in statistical programming, Syneos Health encourages you to apply or join their Talent Network for future opportunities.

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