Principal Clinical Statistical Programmer (Portfolio Development / Biometrics / Programming)
Core
Lead statistical programming across a compound or programme, ensuring consistency of standards and approach for integrated analyses and regulatory submissions.
Role type
Principal Clinical Statistical Programmer (Portfolio Development / Biometrics / Programming)
Builds
Submission-ready data packages, integrated analyses (ISS/ISE), pooled datasets, and reviewer guides (cSDRG/ADRG)
Domain
Pharmaceutical/Biotech clinical research
Required skills
Expert SAS (Base/Macro/Stat/Graph), CDISC standards (CDASH, SDTM, ADaM, define.xml), regulatory submission support, CRO programming oversight, team leadership/mentoring, hands-on programming
Preferred skills
R programming, experience with PMDA/NMPA/EMA submissions
Technologies
SAS, R, CDISC standards
Responsibilities
Lead programming for a compound or programme across multiple clinical trials; Plan and deliver integrated analyses and pooled datasets; Define programming strategy for outsourced studies and hold CROs to submission standard; Act as programming point of contact for regulatory submissions and agency queries; Lead and mentor other programmers; Contribute to departmental standards, macros, and process improvement
Seniority
Principal, hands-on IC with strategic oversight
