Senior Statistical Programmer

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🖥 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

• 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 team members informed of programming progress and issues • Follow applicable SOPs, work instructions, and relevant regulatory guidelines such as ICH • Maintain complete, current project documentation, testing, verification, and quality control documents and programs • Manage scheduling and time constraints across multiple projects and adapt workload to changing priorities • Develop specifications for datasets and outputs of varying complexity according to statistical and sponsor requirements • Anticipate and address programming issues and define variables for peer review and sponsor/requestor approval • 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 timelines • 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 statistical programming representative • Mentor programming personnel through training, work review, feedback, and process guidance • 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 • Excellent written and verbal communication skills • Ability to read, write, speak and understand English • Ability to develop custom programming code for clinical trial outputs • Knowledge of statistical analysis plans, programming specifications, annotated CRFs, and SAS database design • Knowledge of applicable SOPs, work instructions, and relevant regulatory guidelines such as ICH • Ability to lead statistical programming activities and direct other programming personnel • Ability to manage multiple projects, schedules, priorities, and deadlines • Ability to prepare and maintain project documentation, testing, verification, and quality control records • Ability to participate in sponsor, kickoff, and bid defense meetings • Ability to mentor programming personnel and develop or present training materials

🏖️ 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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