Principal Stat Programmer – ADaM, TLF

🕒 September 2

🇮🇳 India – Remote

⏰ Full Time

🔴 Lead

🖥 Software Engineer

👻 Ghost score 20%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Use SAS or other software to develop custom programming code for summary tables, data listings, graphs, and derived datasets according to statistical analysis plans and programming specifications • Ensure outputs meet quality standards and project requirements • Perform validation programming and resolve discrepancies or findings with programmers, biostatisticians, and project team members • Follow applicable SOPs, WIs, and regulatory guidelines such as ICH • Maintain complete, current project documentation, testing, verification, and quality-control materials for inspection readiness • Manage schedules and priorities across multiple concurrent projects • Develop specifications for datasets and outputs of any complexity • Conduct internal meetings, distribute information and minutes, and track action items • Deliver concurrent programming deliverables on time and provide risk mitigation plans • Act as lead statistical programmer, directing programming activities and monitoring deliverables • Review statistical analysis plans, mock shells, programming specifications, annotated CRFs, and SAS database designs • Participate in sponsor, kickoff, and bid defense meetings as statistical programming representative • Mentor programming personnel through training, work review, feedback, and guidance • Serve as a technical expert on clinical drug development, industry standards, and electronic submission requirements • Establish SOPs, guidelines, policies, and procedures with biostatistics and statistical programming personnel • Develop programming tools and macros for standardization and efficiency • Provide guidance and training on CDISC Standards • Perform compliance reviews of SDTM and ADaM specifications and datasets and regulatory documents such as DEFINE.XML • Participate in industry standards organizations and communicate upcoming standards changes • Transfer deliverables • Perform other work-related duties as assigned • Minimal travel may be required

🎯 Requirements

• Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience • 8+ years programming experience in Clinical SAS, demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers • Strong experience in ADaM & TLF • Experience in submissions to a regulatory agency preferred • Experience of pooling study preferred/good to have • Experience mentoring others in clinical trial process and CDISC Standards • Excellent written and verbal communication skills • Ability to read, write, speak and understand English • Minimal travel may be required

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate