Principal Statistical Programmer, ADAM, TLF, SDTM

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🔴 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

• Develop SAS or other software programming code to generate 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 regulatory guidelines such as ICH • Maintain complete project documentation, testing, verification, and quality-control programs for inspection readiness • Manage schedules and priorities across multiple concurrent projects • Develop complex dataset and output specifications according to statistical or sponsor requirements • 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 deliverable progress • 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, and electronic submission requirements • Contribute to SOPs, guidelines, policies, programming tools, and macros • Provide guidance and training on CDISC standards • Perform compliance reviews of CDISC deliverables, including SDTM and ADaM specifications and datasets and DEFINE.XML • Participate in industry standards organizations and communicate upcoming standards changes • Transfer deliverables and perform other assigned work-related duties

🎯 Requirements

• 8+ years of experience in Clinical SAS Programming • Strong expertise in Base SAS/SAS Macros • Expertise in SDTM, ADaM, and TLF programming • Experience creating specifications • Hands-on experience with both Safety and Efficacy data • Oncology therapeutic area experience preferred • ISS/ISE experience • R programming • Excellent written and verbal communication skills • Ability to read, write, speak, and understand English • Immediate joiners preferred • 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 • Total Self culture supporting authenticity and employee care • Diversity, inclusion, and belonging-focused workplace culture