Principal Statistical Programmer

🔥 4 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🔴 Lead

🖥 Software Engineer

👻 Ghost score 10%

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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

• 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 • Follow applicable SOPs, WIs, and relevant regulatory guidelines such as ICH • Maintain complete, current project documentation, testing, verification, and quality-control materials • Manage schedules and priorities across multiple concurrent projects • Develop specifications for datasets and outputs of varying complexity • Conduct internal meetings, distribute information, and follow action items through completion • Deliver concurrent programming projects on time and provide risk-mitigation plans • Lead statistical programming activities and direct other programming personnel • 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, 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 CDISC deliverables, including SDTM and ADaM specifications and datasets and DEFINE.XML • Participate in industry standards organizations and communicate updates on standards • Transfer deliverables • Perform other work-related duties as assigned

🎯 Requirements

• Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment • Ability to lead multiple complex and/or global projects with teams of statistical programmers • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements • Experience in submissions to a regulatory agency preferred • Experience in mentoring others in clinical trial process and CDISC Standards • Excellent written and verbal communication skills • Ability to read, write, speak and understand English

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Minimal travel may be required