Principal Statistical Programmer (ADAM + TFL)
Updated: Today
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002899
Description
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. With our patient-centric Clinical Development model, we aim to simplify and streamline processes, making us easier to work with and for. Whether partnering as a Functional Service Provider or within a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help achieve customer goals. At Syneos Health, we are driven by the passion to change lives.
Why Syneos Health
We are passionate about developing our people, offering career development and progression, supportive management, technical training, and peer recognition. Our Total Self culture unites us globally and fosters an environment where everyone feels like they belong.
Job Responsibilities
The ideal candidate will have over 5 years of experience in statistical programming within clinical research, supporting Phase 2 and Phase 3 studies. Responsibilities include leading programming activities, overseeing deliverables, and ensuring regulatory compliance.
Develops custom programming code in SAS or other software to generate summary tables, data listings, graphs, and derived datasets according to the statistical analysis plan and programming specifications.
Ensures output quality and project requirements are met.
Performs validation programming and works with biostatisticians and team members to resolve discrepancies.
Keeps team members informed of progress and issues.
Follows SOPs, WIs, and regulatory guidelines (e.g., ICH).
Maintains well-organized project documentation and quality control materials, ensuring inspection readiness.
Manages scheduling and time constraints across multiple projects, adapting to changes in workload priorities.
Develops dataset and output specifications and proactively resolves programming issues.
Leads internal meetings, distributes information, and ensures timely action items completion.
Accountable for on-time delivery of programming deliverables and informs management of any issues and resolutions.
Leads programming activities and mentors junior programming personnel.
Reviews project documentation and provides feedback to team members.
Participates in sponsor meetings and bid defense meetings as statistical programming representative.
Contributes to mentoring programming personnel and training development.
Maintains knowledge of clinical drug development and industry standards, serving as a technical expert for complex programming issues.
Works with teams to establish SOPs and standardization tools for efficiency.
Serves as a subject matter expert for CDISC standards and ensures compliance with regulatory requirements.
Minimal travel required.
Qualifications
Undergraduate degree in a scientific or statistical discipline or equivalent experience.
Extensive programming experience in SAS, preferably in a clinical trial environment.
Knowledge of CDISC Standards and regulatory submissions.
Experience mentoring others in clinical trial processes and CDISC Standards.
Excellent communication skills in written and verbal English.
Additional Information
Tasks and responsibilities may change as per the company's discretion. Equivalent experience or skills may be considered. Syneos Health is committed to diversity, inclusion, and equal employment opportunities, ensuring reasonable accommodations when appropriate.
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