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Tier-1 employer and metro location increase competition, though niche CDISC/Pinnacle21 skills limit applicant pool.
Clinical trials CDISC and regulatory submission expertise are highly domain-specific and not easily transferable across industries.
Mandatory SAS, CDISC, Pinnacle21, safety/efficacy expertise and leadership increase candidate filtering strictness.
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Develop and validate complex clinical datasets and outputs using SAS, ensuring compliance with CDISC ADaM and SDTM standards.
Perform Safety and/or Efficacy analysis programming including creation of efficacy datasets, outputs, and writing ADaM specifications.
Provide technical guidance, mentor junior programmers, and support regulatory submission documentation including ADRG and Define.xml.
Minimum 1 year hands-on R programming experience required.
Experience in Safety OR Efficacy analysis programming with efficacy datasets and outputs creation.
Bachelor's Degree in Statistics, Computer Science or related field required; Master's preferred.
Work Experience Required: Not explicitly mentioned in the JD.
Strong expertise in SAS programming and CDISC standards (ADaM, SDTM) with demonstrated project management skills.
Experience leading programming teams and mentoring junior staff to maintain standards and quality.
Ability to work within tight deadlines and collaborate effectively with cross-functional teams.