Principal Statistical Programmer

🕒 September 21

🇮🇳 India – Remote

⏰ Full Time

🔴 Lead

🖥 Software Engineer

👻 Ghost score 34%

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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 with programmers, biostatisticians, and project team members • Keep project teams informed about programming progress and issues • Follow applicable SOPs, work instructions, and regulatory guidelines such as ICH • Maintain complete, current project documentation, testing, verification, and quality-control records and programs • Manage schedules and priorities across multiple concurrent projects • Develop specifications for datasets and outputs of varying complexity • Conduct internal meetings, distribute information and 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, industry standards, CDISC, and electronic submission requirements • Contribute to SOPs, guidelines, policies, procedures, programming tools, and macros • Provide CDISC guidance and training and conduct 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 substitute for the 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 using CDISC Standards for regulatory agency requirements • Experience in submissions to a regulatory agency 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

🏖️ 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

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