Principal Statistical Programmer

• Primary Purpose The Principal Statistical Programmer I provides lead statistical programming support for complex clinical research projects, utilizes advanced SAS programming techniques and offers expert consultation across the company
• Key responsibilities include ensuring the use of sound methodologies, delivering key regulatory-compliant output, developing organized programming documentation, writing efficient code, and mentoring staff
• This role also provides project updates to management while performing assigned duties and presents internally on statistical programming topics
• Expertise in statistical programming techniques and strong communication skills are essential for success in this role
• Responsibilities Provides lead statistical programming support for multiple complex clinical research study projects or study teams
• Provides advanced statistical programming development with SAS (Base, Macros and SQL) and provides expert consultation to projects across the company including statistical programming methodology
• Ensures that sound methodologies are adopted by establishing advanced knowledge of programming techniques required for clinical trials research which involve either CDISC standards and analysis data sets or production of standard and custom tables listings and figures
• Provides key deliverables based on established advanced knowledge of regulatory requirements for clinical research E-submissions and/or study requirements for Sponsor, Regulatory, Investigator or Safety review meetings
• Develops well organized programming documentation and annotations including specifications, review of mock shells, adhering to relevant Standard Operating Procedures and contributes to standardization efforts
• Writes well-documented, efficient, and high-quality code, conducts code review, supports cross-functional programming activities, and programming validation as needed
• Develops expertise in current statistical programming techniques to develop reproducable code and ensure the adoption of sound methodologies
• Presents statistical programming topics internally and may present at external conferences
• Serves as a mentor to statistical programming staff
• Provides project updates to appropriate project management or department management staff
• Other duties as assigned
• Qualifications A bachelors degree plus 6 years or masters/doctoral degree plus 4 years Statistical programming experience as a CDISC/TLF Statistical programmer in Pharmaceutical/CRO environment, education in a scientific discipline preferred
• Understanding of GCP principles and other regulatory standards (eg
• FDA, EMA, and ICH guidance and recommendations) in Clinical Research
• Good analytical skills with the ability to process scientific and medical data
• Ability to manage multiple tasks and priorities independently
• Ability to work independently as well as in a team environment
• Strong skills in prioritization, problem-solving, organization, decision-making, and time management
• Ability to articulate complex and advanced programming and technical concepts through written and oral communication
• Excellent communication, interpersonal and organization skills
• Self-motivated, proactive and detail oriented
• Strong statistical programming skills in SAS, familiarity with R, Python or other relevant statistical software considered beneficial

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