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Tier-1 employer, metro location, mid-level requirement increases applicant density despite niche CDISC/SAS specialization.
Role requires specialized clinical trial/CDISC/SAS expertise, limiting transferability across industries.
Explicit 6+ years, mandatory CDISC/SAS expertise, regulatory and leadership requirements enforce strict filtering.
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Lead end-to-end statistical programming for one or more clinical studies as Study Lead Programmer, ensuring quality, compliance, and timelines of all deliverables.
Set programming strategy, manage team assignments, and coordinate programming tasks including integrated analysis for regulatory submissions.
Provide technical leadership, create programming specifications (SDTM, ADaM), participate in cross-functional study activities, and support product-level responsibilities as delegated.
Bachelor's degree in biostatistics, statistics, mathematics, computer science, or related quantitative/scientific field.
At least 6 years of statistical programming experience in clinical development environment.
Thorough understanding of clinical trial processes and demonstrated ability to lead and manage statistical programming teams successfully.
Expertise in CDISC SDTM, ADaM, Define standards and advanced SAS programming skills including SAS/STAT packages.
Experienced leader with proven record of managing multiple clinical study programming projects end-to-end within global teams.
Strong project management skills and ability to coordinate across cross-cultural and globally dispersed teams.
Technical proficiency beyond SAS, including familiarity with open-source tools (R, Python) and experience with regulatory submissions is advantageous.