SDTM SME

This position is Full-Time and remote anywhere in North America

This role is in support of Programming SDTM, ADaM, and analysis reporting (TFL) Standards. Candidates should be experienced Statistical Programmers capable of the skills and responsibilities described below. This role does not involve actual study work but requires a high degree of self-motivation/direction and attention to detail, as well as exceptional problem solving, oral & written communication, multi-tasking and team working skills.

Key Responsibilities:

• Programming standardization activities and departmental initiatives.
• Collaborate cross-functionally with Macro team and CDMA as needed.
• Successfully interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis.
• Expert knowledge of SDTM and ADaM data standards and FDA/PMDA/EMA submission requirements required.
• Develop, update, and maintain analysis reporting (TFL) standards.
• Review and align current ADaM Client CORE standards to Regulatory Agency requirements, CDISC TAUGS, and CDISC standards.
• Review SDTM standards for updates and impacts on current ADaM CORE standards.
• Participate in study specific ADaM submission package reviews across multiple authorities.

Requirements:

• Bachelors Degree or Masters Degree in a science related field and 8+ years clinical trials industry experience
• Must have experience working on a Global Standards team or have created Global Standards for at least 3 years

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $117,400.00 - $218,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.