Principal Statistical Programmer in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Statistical Programmer in United States.

This senior-level role plays a critical part in supporting clinical development and regulatory submissions through high-quality statistical programming and data standardization. You will lead complex programming activities across clinical trials, ensuring accuracy, reproducibility, and compliance with global regulatory standards. The position focuses heavily on CDISC implementation, particularly SDTM standards and submission deliverables, with direct impact on regulatory readiness. You will collaborate closely with cross-functional biometrics, clinical, and regulatory teams to support data-driven decision-making. The role requires both deep technical expertise and the ability to guide and mentor junior programmers. In addition, you will contribute to process optimization and the development of programming standards and tools. This is a high-impact opportunity within a fast-evolving biopharmaceutical environment focused on advancing innovative therapies.

• Lead end-to-end statistical programming activities for clinical trial data, ensuring accuracy, efficiency, and compliance with regulatory standards
• Oversee the creation, validation, traceability, and maintenance of analysis datasets and statistical outputs
• Develop and review CDISC SDTM datasets and regulatory submission deliverables including Define.xml, SDTM aCRF, and cSDRG
• Contribute to statistical analysis plans and ensure alignment with submission requirements for regulatory agencies
• Support data standardization efforts across CRF design, database structures, edit checks, and CDISC implementation (SDTM/ADaM)
• Collaborate with cross-functional clinical development and regulatory teams as a key biometrics contributor
• Design and optimize global programming macros, tools, and processes to improve efficiency and consistency
• Provide mentorship, training, and technical guidance to junior statistical programmers
• Participate in resource planning, project budgeting, and long-term programming strategy
• Contribute to SOP development, process improvements, and standardization initiatives

Requirements:

• Bachelor’s degree in Statistics, Biostatistics, Computer Science, or Mathematics with 10+ years of relevant experience, or Master’s degree with 8+ years of experience
• At least 5 years of experience in statistical programming within the pharmaceutical or clinical research industry
• Strong expertise in CDISC SDTM standards and regulatory submission deliverables
• Advanced proficiency in SAS programming and clinical data analysis
• Solid understanding of clinical research processes, Good Clinical Practices, and regulatory requirements
• Proven experience leading programming activities across multiple concurrent clinical projects
• Strong analytical and problem-solving skills with the ability to manage complex datasets and requirements
• Excellent communication skills in English, both written and verbal, with strong collaboration abilities
• Experience mentoring or guiding junior team members is highly valued
• Strong organizational skills and ability to work in a structured, deadline-driven environment

Benefits:

• Competitive annual base salary ranging from $162,000 to $190,000 depending on experience and location
• Eligibility for discretionary bonus and equity awards
• Comprehensive medical, dental, and vision insurance coverage
• Retirement savings plan with company match (401k)
• Flexible spending accounts for healthcare and dependent care
• Paid time off including holidays, vacation, and additional personal and wellness days
• Unlimited PTO option for eligible employees
• Life, AD&D, short-term and long-term disability insurance (company-paid and voluntary options)
• Employee wellness programs, mental health support, and assistance services
• Additional perks including identity protection, pet insurance, legal services, and employee discounts
• Flexible work arrangement (onsite or remote depending on location).