Principal Stat Programmer – ADaM, TLF

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🔴 Lead

🖥 Software Engineer

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Syneos Health

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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

• Develop custom programming code using SAS or other software to generate summary tables, data listings, graphs, and derived datasets • Ensure outputs meet quality standards and project requirements • Perform validation programming and resolve discrepancies with programmers, biostatisticians, and project team members • Keep project teams informed of programming progress and issues • Follow applicable SOPs, work instructions, and regulatory guidelines such as ICH • Maintain complete, organized, up-to-date project documentation, testing, verification, and quality-control materials • Manage schedules and priorities across multiple concurrent projects • Develop specifications for datasets and outputs according to statistical or sponsor requirements • Conduct effective internal meetings, distribute information, document minutes, and track action items • Deliver concurrent programming work on time and provide risk-mitigation plans • Act as lead statistical programmer, direct other programming personnel, and monitor deliverables • Review statistical analysis plans, mock shells, programming specifications, annotated CRFs, and SAS database designs • Participate in sponsor, kickoff, and bid-defense meetings as the statistical programming representative • Mentor programming personnel through training, work review, feedback, and guidance • Serve as a technical expert on clinical drug development, CDISC, regulatory requirements, and complex programming questions • Help establish SOPs, guidelines, policies, and procedures • Contribute technical expertise to programming tools and macros • Provide CDISC guidance and training and perform compliance reviews of SDTM, ADaM, and DEFINE.XML deliverables • Participate in industry standards organizations and communicate standards updates • Transfer deliverables and perform other assigned duties

🎯 Requirements

• Undergraduate degree, preferably in a scientific or statistical discipline; an equivalent combination of education and demonstrated programming experience may be accepted in lieu of a degree • 8+ years of programming experience in Clinical SAS • Ability to lead multiple complex and/or global projects with teams of statistical programmers • Strong experience in ADaM and TLF • Experience in submissions to a regulatory agency preferred • Experience of pooling study preferred • Experience mentoring others in clinical trial processes and CDISC Standards • Excellent written and verbal communication skills • Ability to read, write, speak, and understand English • Knowledge of clinical drug development, industry standards, electronic submission requirements, CDISC, SDTM, ADaM, and DEFINE.XML • 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

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