Senior Principal Statistical Programmer

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a senior technical authority in statistical programming for various studies or functional areas.

• Design, create, validate, and supervise intricate statistical programming outputs, such as analysis datasets, tables, listings, and figures.

• Lead the development, validation, and ongoing enhancement of DMC macros and programming standards.

• Provide technical guidance and review of programming tasks.

• Establish and promote the adoption of programming standards, best practices, and process enhancements.

• Collaborate with biostatistics and study teams on intricate trial designs, analyses, and DMC reporting.

• Manage and prioritize programming tasks across multiple studies or initiatives.

• Mentor statistical programming personnel and offer technical leadership.

• Contribute technical knowledge to proposals, project planning, and scope discussions.

• Partner with IT and technology teams regarding SAS environments, tools, and system validation.

• Provide technical oversight for regulatory submissions and readiness for inspections.

• Ensure that deliverables meet regulatory expectations, submission criteria, and CDISC standards.

• Serve as a technical escalation resource and lead the resolution of complex programming, data, or deliverable challenges.

• Interpret SAPs, protocols, and study documents, translating requirements into programming strategies.

• Advocate for process improvements, automation, and innovative strategies to enhance efficiency and consistency.

• Perform additional duties as assigned by the supervisor.

⛳️ Requirements

• A Master's degree is required; in specific cases, an equivalent combination of education and directly related professional experience may be accepted.

• A minimum of 8–10 years of statistical programming experience in a clinical trial setting.

• Extensive expertise in SAS programming, including complex analyses and regulatory deliverables.

• Proficiency in R programming is essential.

• Demonstrated experience with CDISC standards and regulatory requirements.

• Proven capability to independently lead complex programming projects across studies.

• Experience in mentoring staff and promoting technical standards or best practices.

• Demonstrated capacity to independently coordinate biostatistical projects, managing programming activities with minimal direction from senior leadership.

• Ability to satisfactorily perform each essential duty and responsibility.

🏝️ Benefits

• Medical, dental, vision, life, and disability insurance.

• 401(k) with company match.

• Flexible spending accounts.

• Employee assistance programs.

• Work/life balance tools.

• Referral bonuses.

• Tuition reimbursement.

• On-the-job training.

• Certification assistance.

• Continuing education support.

• Paid holidays, vacation, and sick time.

• Career development opportunities across One WCG.