Associate Director, Statistical Programming
Core
Lead statistical programming activities across clinical development programs, ensuring quality standards for regulatory submissions, CSRs, and publications.
Role type
Associate Director, Statistical Programming
Builds
Regulatory submissions (INDs, IBs, NDA/BLAs), Clinical Study Reports, abstracts, publications
Domain
Clinical biotechnology, oncology, infectious disease, inflammatory gastrointestinal disease
Required skills
CDISC standards (SDTM, ADaM), SAS, regulatory submission data preparation, pivotal trial support, CRO/vendor oversight, SOP development, Pinnacle 21
Preferred skills
R
Technologies
SAS, Pinnacle 21, R
Responsibilities
Lead statistical programming activities across clinical development programs; Program and validate deliverables for interim and final analyses, publications, abstracts, CSRs, and regulatory submissions; Collaborate with study biostatisticians to develop and implement TLF programming for statistical analysis plans; Assist data management in the development and programming of non-system edit checks for clinical trial data; Develop and maintain the statistical programming environment for biometrics; Provide hands-on oversight of CROs and external statistical programming groups; Develop SOPs for statistical programming function
Seniority
Senior, hands-on IC with leadership
