Principal Stat Programmer, SDTM, ADaM, TLF

🔥 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

• 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, WIs, and regulatory guidelines such as ICH • Maintain complete, current project documentation, testing, verification, quality control documents, and programs • Manage schedules and time constraints across multiple projects and adapt workload to changing priorities • 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, directing programming activities 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, and electronic submission requirements • Establish SOPs, guidelines, policies, and procedures with biostatistics and statistical programming personnel • Develop programming tools and macros for standardization and efficiency • Provide guidance and training on CDISC standards • Perform compliance reviews of SDTM and ADaM specifications, datasets, and regulatory documents such as DEFINE.XML • Participate in industry standards organizations and communicate upcoming standards changes • Transfer deliverables • Perform other assigned work-related duties

🎯 Requirements

• Advanced degree in Statistics, Computer Science, or a related field • Proven experience in statistical programming and data analysis • Strong knowledge of SAS, R, or Python • Familiarity with data visualization tools and techniques • Excellent problem-solving and analytical skills • Ability to work independently and manage multiple projects simultaneously • SAS Certified Advanced Programmer for SAS 9 or equivalent certification • Certification in data analysis or statistical programming is preferred • Proficiency in statistical programming and data manipulation • Strong understanding of statistical methodologies and data analysis techniques • Ability to develop and implement efficient programming solutions • Excellent communication and collaboration skills • Attention to detail and commitment to quality • Ability to adapt to changing project requirements and priorities • Equivalent experience, skills, and/or education will also 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