Statistical Programmer, SDTM, ADAM, TLF

🔥 51 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🖥 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

• Use SAS or other software to develop 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 with programmers, biostatisticians, and project team members • Follow applicable SOPs, work instructions, and relevant regulatory guidelines such as ICH • Maintain complete project documentation, testing, verification, and quality-control materials for inspection readiness • Manage schedules and time constraints 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 deliverables 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 • Mentor programming personnel through training, work review, and feedback • Serve as a technical expert on clinical drug development, industry standards, electronic submissions, CDISC, SDTM, and ADaM • Perform compliance reviews of CDISC deliverables, specifications, datasets, and regulatory documents such as DEFINE.XML • Participate in industry standards organizations and communicate standards updates • Contribute to SOPs, policies, procedures, programming tools, and macros • Transfer deliverables • Perform other assigned work-related duties

🎯 Requirements

• 8+ years programming experience in Clinical Statistical Programming • Ability to lead multiple complex and/or global projects with teams of statistical programmers • Strong experience in SDTM, ADAM & TLF • Experience writing SDTM/ADAM specifications • Experience with oncology efficacy endpoints/outputs • Experience in submissions to a regulatory agency preferred • Experience in R programming • Excellent written and verbal communication skills • Immediate joiners preferred • Equivalent experience, skills, and/or education may be considered

🏖️ 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