Principal Statistical Programmer

We are seeking an experienced Principal Statistical Programmer to lead statistical programming activities for clinical development programs. The ideal candidate will have strong expertise in SAS programming, CDISC standards, ADaM datasets, TLF development, regulatory submissions, and clinical trial data analysis. This role will provide technical leadership, mentor statistical programmers, and collaborate with cross-functional clinical teams.

Required Skills & Experience

• Experience leading a team of statistical programmers supporting clinical development programs.
• Strong proficiency in SAS programming for developing and validating:
  • ADaM datasets
  • Tables, Listings, and Figures (TLFs)
  • Statistical analyses
• Good knowledge of R programming and other statistical programming languages preferred.
• Strong understanding of SAS programming concepts and the clinical study lifecycle.
• In-depth knowledge of CDISC standards (SDTM/ADaM) and regulatory requirements.
• Experience supporting regulatory filings and submission documentation.
• Experience working in therapeutic areas such as Oncology, Immunology, Neuroscience, or similar domains.
• Strong communication and collaboration skills with cross-functional teams.
• Ability to estimate project programming efforts and manage competing priorities.

Roles and Responsibilities

• Lead statistical programming activities for assigned compounds, indications, or therapeutic areas.
• Manage and mentor statistical programmers, analysts, and senior analysts.
• Plan resources, track deliverables, and ensure timely completion of programming activities.
• Develop and oversee SAS programs for ADaM dataset creation following CDISC standards.
• Develop and review SAS programs for Tables, Listings, and Figures (TLFs).
• Ensure consistency and quality of ADaM datasets across individual studies and integrated analyses.
• Support regulatory submissions by preparing documentation such as reviewer guides and data definition documents.
• Develop standard SAS macros, programming standards, and operating procedures.
• Ensure compliance with quality processes and clinical programming best practices.
• Collaborate with Statisticians, Clinical Data Management, Medical Writing, Regulatory Publishing, and Clinical Operations teams.

Preferred Qualifications

• Experience in pharmaceutical, biotechnology, or clinical research environments.
• Strong knowledge of clinical trial programming and regulatory submission processes.
• Excellent leadership, problem-solving, and organizational skills.
• Ability to work effectively in a dynamic, deadline-driven environment.

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