Pr Statistical Programmer(ADAM, TLF, SDTM)

Syneos Health, Inc.

Job Overview

Location

IND-Remote

Job Type

Full-time

Full Job Description

📋 Description

• Develops custom SAS programming code to generate summary tables, data listings, graphs, and derived datasets in accordance with statistical analysis plans and programming specifications, ensuring outputs meet quality standards and project requirements.
• Performs validation programming and collaborates with biostatisticians and other programmers to resolve discrepancies and ensure data integrity.
• Adheres to standard operating procedures (SOPs), work instructions (WIs), and regulatory guidelines including ICH standards.
• Maintains comprehensive, organized, and up-to-date project documentation, testing logs, and quality control records to ensure inspection readiness.
• Manages multiple concurrent projects by prioritizing deliverables, adapting to shifting timelines, and reorganizing daily workloads to meet deadlines.
• Creates detailed specifications for complex datasets and outputs based on statistical or sponsor requirements, anticipating programming challenges to minimize rework and ensure peer and sponsor approval.
• Leads internal meetings with appropriate frequency and format, distributes pre-read materials, ensures accurate minutes, and follows through on action items to drive project progress.
• Acts as lead statistical programmer by directing the work of junior programming staff and monitoring progress on all programming deliverables.
• Reviews key project documents including Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database designs to provide feedback that improves efficiency and reduces errors.
• Represents the statistical programming team in sponsor meetings, kickoff sessions, and bid defense meetings as required.
• Mentors junior programming personnel through training development, work reviews, feedback sessions, and process guidance.
• Maintains expert-level knowledge of clinical drug development, industry standards, and electronic submission requirements, serving as a technical resource for complex programming questions across the department.
• Contributes to the development and standardization of programming tools, macros, and automation scripts to enhance efficiency and consistency.
• Serves as a subject matter expert for CDISC standards, providing guidance and training on SDTM, ADaM, and DEFINE.XML compliance across the Biometrics group and other departments.
• Conducts compliance reviews of project deliverables to ensure adherence to CDISC and regulatory requirements for SDTM, ADaM, and related documentation.
• Actively participates in industry standards organizations and communicates updates on regulatory and CDISC standard changes to the Biometrics team.
• Transfers final deliverables to sponsors or regulatory bodies as required.
• Performs additional work-related duties as assigned, with minimal travel expected.

🎯 Requirements

• 8+ years of experience in Clinical SAS Programming
• Strong expertise in Base SAS, SAS Macros, SDTM, ADaM, and TLF programming and specification creation
• Hands-on experience with both Safety and Efficacy datasets
• Must have experience with ISS/ISE and R programming
• Excellent written and verbal communication skills
• Ability to read, write, speak, and understand English

🏖️ Benefits

• Career development and progression opportunities
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Inclusive culture supporting authentic self-expression
• Purpose-driven work focused on accelerating patient progress

Skills & Technologies

Remote

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Syneos Health, Inc.

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About Syneos Health, Inc.

Syneos Health is a global biopharmaceutical services organization providing clinical and commercial solutions. It integrates clinical development, outsourced commercialization, consulting, and communications services to accelerate the delivery of therapies to market. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of product development and commercialization, operating in North America, Europe, and Asia-Pacific.

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