Statistical Programmer

🔥 18 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🖥 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 • Keep project teams informed of programming progress and issues • Follow applicable SOPs, work instructions, and regulatory guidelines such as ICH • Maintain complete, current project documentation, testing, and quality-control materials • Manage schedules and priorities across multiple concurrent projects • Develop specifications for datasets and outputs according to statistical or sponsor requirements • Lead effective internal meetings and track action items • Deliver concurrent programming deliverables on time and provide risk mitigation plans • Act as lead statistical programmer 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 • Mentor programming personnel through training, work review, and feedback • Serve as a technical expert on clinical drug development, industry standards, and electronic submissions • Establish SOPs, guidelines, policies, and procedures with biostatistics and statistical programming teams • Develop programming tools and macros for standardization and efficiency • Provide guidance and training on CDISC Standards • Perform compliance reviews of CDISC deliverables, including SDTM, ADaM, and DEFINE.XML • Participate in industry standards organizations and communicate upcoming standards changes • Transfer deliverables • 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 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