Job Description

Job Description

This is a Contractor - Senior statistical programmer - Remote position in a CRO company. This position will play a key role in the development, validation, and maintenance of clinical trial data analyses. This position ensures compliance with CDISC standards, adherence to regulatory requirements, and efficient execution of statistical programming deliverables. The role involves developing and validating datasets, tables, listings, and figures (TLFs) to support drug development and regulatory submissions for multiple indications.

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Key Responsibilities

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• Preference for candidates in EST or a similar time zone
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• 5–10 years of clinical trial programming experience
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• Strong Phase2/Phase3 experience, with an emphasis on ADaM dataset programming and TFL development
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• Strong SDTM experience is preferred but not required
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• Ability to work independently, including programming without detailed data specifications
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• Experience supporting internal data requests and working in a fast-paced, growing environment
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• Ability to prioritize urgent requests and multitask effectively
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• Asthma experience is a plus but not required
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• Submission experience is also a plus
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• Experience with R and/or Python is a nice-to-have
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• Preference for candidates who have worked within a small-to-midsize sponsor environment
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Qualifications

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• Bachelor’s or Master’s degree in Statistics, Computer Science, or a related field.
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• Minimum 5 years of relevant experience in the biopharmaceutical, biotechnology, or CRO industry.
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• Experience in late-phase (phase III) trials is highly desirable.
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• Proficiency in SAS programming.
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• Hands-on experience with raw datasets, SDTM, and ADaM dataset development.
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• Strong analytical, problem-solving, and communication skills (both verbal and written).
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• Ability to work effectively in a cross-functional environment, proactively influencing teams with innovative clinical development strategies.
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