Job Title:
Principal Statistical Programmer (ADaM + TFL)
Company:
Syneos Health
Location:
India-Asia Pacific - Home-Based, India
Job ID:
25002899
Job Type:
Full-Time
Role Overview:
The Principal Statistical Programmer will lead programming activities in clinical trials, ensuring the generation of ADaM datasets, TFLs (tables, figures, listings), and supporting regulatory submissions. This role involves mentoring, guiding a team of programmers, and ensuring that project deliverables are completed on time while maintaining the highest standards of quality.
Key Responsibilities:
Programming and Data Analysis:
Use SAS or other programming software to develop custom code for generating summary tables, data listings, graphs, and derived datasets as per the statistical analysis plan.
Ensure outputs meet the required quality standards and specifications.
Perform validation programming, resolving discrepancies or findings in collaboration with biostatisticians and other team members.
Manage scheduling and timelines across multiple projects, adapting workload based on priority changes.
Team Leadership and Mentoring:
Lead statistical programming activities and guide other programmers.
Act as a technical subject matter expert, particularly on CDISC standards (SDTM, ADaM) and regulatory requirements.
Mentor junior programming staff by developing training materials and providing feedback on their work.
Regulatory and Compliance:
Contribute to the preparation of submissions for regulatory agencies, including the use of CDISC standards (SDTM, ADaM).
Review project deliverables for CDISC compliance and other regulatory requirements, such as DEFINE.XML.
Participate in industry standards organizations to stay updated on changes to CDISC standards and other regulatory guidelines.
Collaboration and Communication:
Work closely with internal and external project teams, ensuring effective communication and coordination.
Participate in sponsor meetings, bid defense meetings, and provide input from the statistical programming perspective.
Project Management and Deliverables:
Oversee on-time delivery of programming deliverables and ensure quality control measures are in place.
Proactively inform management of the status of deliverables, potential risks, and suggested solutions.
Requirements:
Education:
Undergraduate degree in a scientific or statistical discipline or equivalent education/experience.
Experience:
Minimum of 5 years of programming experience in clinical trials, with significant expertise in SAS, ADaM, and TFL generation.
Proven ability to lead and manage complex and/or global projects, with experience in mentoring and training staff.
Experience with CDISC standards (SDTM, ADaM) and regulatory submissions.
Skills:
Strong written and verbal communication skills.
In-depth knowledge of clinical drug development processes, industry standards, and electronic submission requirements.
Proficiency in SAS and other programming software commonly used in clinical research.
Why Syneos Health?
Syneos Health offers career development opportunities, a supportive culture, and a commitment to diversity and inclusion.
The company has worked with 94% of FDA-approved drugs and 95% of EMA-authorized products in the past 5 years, contributing significantly to the global advancement of clinical therapies.
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