Principal Statistical Programmer
Location: India-Asia Pacific – IND-Home-Based
Job ID: 25002628
Updated: Yesterday
Description:
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage clinical, medical affairs, and commercial insights to deliver innovative outcomes that address real-world challenges.
Our Clinical Development model places the customer and patient at the core of everything we do. We continually explore ways to simplify and streamline our processes, making Syneos Health not only easier to work with but also easier to work for.
Why Syneos Health:
Career development and progression opportunities.
Supportive and engaged line management.
Technical and therapeutic area training.
Peer recognition and total rewards programs.
Total Self culture – enabling individuals to authentically be themselves.
Job Responsibilities:
Develop custom programming code using SAS or other software to generate summary tables, data listings, graphs, and derived datasets as specified in the statistical analysis plan and programming specifications.
Ensure outputs meet quality standards and project requirements.
Perform validation programming and collaborate with other team members to resolve discrepancies.
Keep project teams informed about programming progress and issues.
Adhere to SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).
Maintain complete and up-to-date project documentation, ensuring inspection readiness.
Manage multiple projects, balancing timelines and priorities effectively.
Develop complex dataset and output specifications aligned with sponsor requirements.
Conduct internal meetings, distribute relevant information, and follow through on action items.
Provide technical expertise and serve as the lead statistical programmer.
Review project documentation and offer feedback to improve programming efficiency.
Participate in sponsor meetings, kickoff meetings, and bid defense meetings.
Mentor programming personnel through training and feedback.
Maintain knowledge of clinical drug development, industry standards, and regulatory submission requirements.
Contribute to the development of programming tools, macros, and standardization processes.
Serve as a subject matter expert for CDISC and other industry standards, providing guidance and training.
Perform compliance reviews for CDISC deliverables, including SDTM, ADaM specifications, and DEFINE.XML.
Qualifications:
Undergraduate degree in a scientific or statistical discipline (or equivalent combination of education and experience).
Extensive programming experience in SAS or other software, preferably in a clinical trial environment.
Proven ability to lead multiple complex and/or global projects with teams of statistical programmers.
Knowledge and experience in CDISC Standards and regulatory agency requirements.
Strong written and verbal communication skills.
Ability to read, write, speak, and understand English.
Additional Information:
Tasks and responsibilities may change based on company needs.
Equivalent skills, education, and experience will be considered.
The Company is committed to compliance with the Americans with Disabilities Act and other relevant legislation.
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