You will join a fast-paced, growth-oriented environment where your expertise will help advance clinical development programs and contribute to the delivery of new therapies to patients. With opportunities to work across diverse studies, technologies, and global teams, you will continue to expand your technical capabilities and deepen your impact within clinical research.

Key Responsibilities:

• Deliver high-quality statistical programming services while ensuring timely and cost-effective study execution.
• Serve as Statistical Programming Coordinator on projects, including planning timelines, coordinating programming activities, monitoring project resources, and identifying changes in scope.
• Act as a key sponsor-facing contact for statistical programming matters and provide technical support and guidance to study teams.
• Perform quality control activities for derived datasets, tables, listings, and figures in accordance with company standards, ICH-GCP requirements, and applicable regulations.
• Coordinate study startup activities, including project environment setup, global program development, tracking tools, and required documentation.
• Contribute to the development and quality review of analysis plans, TLF mock shells, derived dataset specifications, programming specifications, and related documentation.
• Develop and quality check derived datasets, tables, figures, and listings using efficient programming techniques.
• Apply industry standards including CDISC, 21 CFR Part 11, electronic submission requirements, and other applicable regulatory requirements.
• Create standard macros, applications, and process improvements that enhance departmental efficiency and consistency.
• Maintain complete study documentation to support traceability, regulatory compliance, and audit readiness.
• Support process improvement initiatives, audits, inspections, and quality management activities.
• Lead, supervise, create, implement, and execute data import and export programming activities, including the development of mapping specifications aligned with applicable standards.

You’ll thrive in this role if you bring:

• Strengths in SAS programming, technical problem solving, and leadership.
• Experience working within the clinical trial industry and regulated environments.
• The ability to collaborate effectively across global and cross-functional teams while working independently when required.
• A quality-focused mindset with strong attention to detail and commitment to first-time quality.
• Comfort working with clinical trial data, statistical programming processes, regulatory requirements, and industry data standards.

Required Qualifications:

• Bachelor's degree in a relevant discipline or equivalent work experience.
• Relevant clinical trial industry experience.
• Proficiency in SAS.
• Knowledge of statistical programming and reporting processes.

Preferred Qualifications:

• 5+ years of experience in end-to-end programming (SDTM, ADaM & TLFs).
• Knowledge of CDISC standards, electronic submission requirements, and clinical data standards.
• Experience supporting audits, inspections, and quality management activities
• Demonstrated ability to create programming efficiencies through standard macros, applications, or process improvements.
• Competent written and spoken English.
• Experience mentoring, training, or providing technical guidance to colleagues and project teams.

Originally posted on Himalayas