Statistical Programmer

🕒 September 23

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🖥 Software Engineer

👻 Ghost score 36%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 51 days.
• Jobs at this company usually fill in 21 days.
• Reposted once.
• No salary listed.

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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

• Use SAS or other software to develop custom programming code for 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 teams informed of programming progress and issues • Maintain complete, current project documentation, testing, verification, and quality-control materials for inspection readiness • Manage scheduling and priorities across multiple concurrent projects • Develop specifications for datasets and outputs of varying complexity • Conduct effective internal meetings, distribute information, document minutes, and track action items • Deliver concurrent programming deliverables on time; negotiate timelines and provide risk-mitigation plans • Act as lead statistical programmer, directing other programming personnel and monitoring 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 reviews, 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 communicate standards updates • Establish SOPs, guidelines, policies, and procedures with biostatistics and statistical programming teams • Contribute technical expertise to programming tools and macros • 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 be accepted 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 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 • Follow applicable SOPs, WIs, and relevant regulatory guidelines such as ICH • 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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