Job Description

Job Title: Statistical Programmer

Location: Remote

Contract Type: Contract

No H1B

About the Role:
We are currently seeking a highly skilled Statistical Programmer with well-documented MMRM (Mixed-Effects Model for Repeated Measures) experience in clinical trials . This is an exciting opportunity for an experienced professional to contribute to impactful clinical research while working remotely.

The ideal candidate is proficient in statistical programming, has hands-on experience with MMRM in clinical trials, and can start immediately. If you are detail-oriented, excel in a fast-paced environment, and are eager to make a difference in clinical research, we encourage you to apply!

Key Responsibilities:

• Develop, validate, and maintain statistical programming code to support clinical trial data analysis.
• Implement MMRM models and other statistical methodologies in compliance with clinical trial protocols.
• Collaborate with statisticians, data managers, and clinical trial teams to ensure accurate and efficient programming solutions.
• Prepare and review programming deliverables, including analysis datasets, tables, listings, and figures (ADaM, SDTM, etc.).
• Ensure all programming deliverables meet regulatory and quality standards (e.g., FDA, ICH guidelines).
• Troubleshoot and resolve data issues and programming errors promptly.
• Document programming processes and maintain clear, reproducible code for audits and reviews.
• Contribute to database setup and ensure alignment with study objectives and analysis requirements.

Qualifications:

• 3+ years of statistical programming experience in the clinical trials or pharmaceutical industry.
• Strong proficiency in SAS programming and familiarity with other programming languages (e.g., R or Python) is a plus.
• Well-documented experience implementing and interpreting MMRM models in clinical trial data analysis.
• Solid understanding of clinical trial data structures, CDISC standards (SDTM/ADaM), and regulatory requirements.
• Strong knowledge of statistical methodologies used in clinical trials, including MMRM and other longitudinal data analysis techniques.
• Familiarity with regulatory submission requirements (FDA, EMA, etc.) and related documentation.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently in a remote environment while collaborating effectively with cross-functional teams.

Preferred Qualifications:

• Advanced degree (Master's or Ph.D.) in Statistics, Biostatistics, Computer Science, or a related field.
• Experience in programming for regulatory submissions and audits.
• Knowledge of additional statistical modeling techniques is a plus.

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