Principal Statistical Programmer, SDTM

🔥 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 • Ensure outputs meet quality standards and project requirements • Perform validation programming and resolve discrepancies with programmers, biostatisticians and project team members • Maintain complete, current project documentation, testing and quality-control records for inspection readiness • Manage scheduling and time constraints across multiple projects • Develop specifications for datasets and outputs according to statistical and sponsor requirements • Prepare for and conduct internal meetings, distribute information and minutes, and follow action items through completion • Establish time estimates and complete study programming activities within allotted timeframes • Act as lead statistical programmer, direct other programming personnel and monitor programming deliverables • Review statistical analysis plans, mock shells, programming specifications, annotated CRFs and SAS database design • Participate in sponsor, kickoff and bid defense meetings as the statistical programming representative • Mentor programming personnel through training, work review, feedback and guidance • Transfer deliverables and perform other assigned duties

🎯 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 • Excellent written and verbal communication skills • Ability to read, write, speak and understand English • Ability to develop custom programming code for summary tables, data listings, graphs and derived datasets • Knowledge of statistical analysis plans, programming specifications, annotated CRFs and SAS database design • Knowledge of applicable SOPs, WIs and relevant regulatory guidelines such as ICH • Ability to perform validation programming and resolve discrepancies • Ability to lead and direct programming activities and monitor deliverables • Ability to manage multiple projects, schedules, priorities and timelines

🏖️ 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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