Principal Statistical Programmer

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🔴 Lead

🖥 Software Engineer

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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 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 • Keep project team members informed of programming progress and issues • Follow applicable SOPs, WIs, and relevant regulatory guidelines such as ICH • Maintain complete, current project documentation, testing, verification, quality control documents, and programs for inspection readiness • Manage schedules and time constraints across multiple concurrent projects • Develop specifications for datasets and outputs of any complexity • Conduct internal meetings, distribute information and minutes, and follow action items to completion • Deliver concurrent programming deliverables on time and provide risk mitigation plans • Act as lead statistical programmer, direct programming activities, 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, industry standards, electronic submissions, CDISC, SDTM, and ADaM • Perform compliance reviews of CDISC deliverables and regulatory documents such as DEFINE.XML • Participate in industry standards organizations and update the Biometrics Department on standards changes • Transfer deliverables and perform other assigned work-related duties

🎯 Requirements

• Undergraduate degree, preferably in a scientific or statistical discipline; an equivalent combination of education and demonstrated programming experience may be considered in lieu of a degree • 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 • 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