Job Title: Principal Statistical Programmer (ADaM + TFL)
Job Location: India - Asia Pacific - Home-Based
Company Overview
Syneos Health is a global leader in biopharmaceutical solutions, providing services in clinical development, medical affairs, and commercialization to accelerate the delivery of therapies. They bring the customer and patient at the center of everything they do, working in over 110 countries.
Role Summary
As a Principal Statistical Programmer, you will lead statistical programming activities, oversee project deliverables, and ensure adherence to regulatory standards and timelines. This position involves working closely with biostatisticians, project teams, and sponsors to deliver high-quality statistical outputs such as ADaM and TFL (Tables, Listings, and Figures).
Key Responsibilities
Develop custom programming code using SAS (or other software) to generate summary tables, data listings, graphs, and derived datasets according to statistical analysis plans.
Ensure that all outputs meet quality standards and project requirements.
Collaborate with other programmers, biostatisticians, and project team members to resolve discrepancies and findings.
Ensure compliance with ICH guidelines and maintain up-to-date project documentation.
Manage multiple projects, set goals based on management priorities, and adapt to changes in timelines or project scope.
Provide specifications for datasets and outputs, ensuring efficient programming and minimizing rework.
Lead and mentor other programming personnel, developing training courses and guiding junior associates.
Oversee the programming activities of other team members, ensuring on-time delivery of concurrent programming deliverables.
Provide technical expertise on CDISC Standards, SDTM, ADaM, and regulatory submissions.
Contribute to the development of programming tools and macros for standardization and efficiency.
Participate in sponsor meetings and contribute to bidding and defense meetings.
Perform internal compliance reviews for regulatory deliverables.
Occasionally attend and participate in industry standards organizations.
Qualifications
Required
Education: Undergraduate degree in a scientific or statistical discipline, or equivalent experience in statistical programming.
Experience:
Extensive experience (5+ years) in SAS programming within clinical trials.
Proven ability to lead complex and global projects with programming teams.
Knowledge and experience with CDISC Standards for regulatory submissions.
Experience in mentoring others in the clinical trial process and CDISC standards.
Excellent written and verbal communication skills, fluent in English.
Preferred
Experience with submissions to regulatory agencies and familiarity with regulatory standards.
Familiarity with mentoring and leadership in a clinical programming environment.
Work Environment
Syneos Health promotes a Total Self culture where employees are encouraged to be their authentic selves. The company provides career development opportunities, a peer recognition program, and a supportive work environment to help employees succeed.
How to Apply
Interested candidates can apply through the Syneos Health career portal.
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