Senior Clinical Statistical Programmer (Portfolio Development / Biometrics / Programming)
- Hiring Organisation
- CSL
- Location
- Maidenhead, Berkshire, United Kingdom
- Salary
- £ 70 K
handled by a CRO· Mentor other programmers on internal processes and standards, and contribute to departmental tools and process improvements· Take on ad hoc analytical work — regulatory query responses, exploratory analyses, publication support — as studies require itExperience Required· Experience of programming in pharmaceutical, biotech, CRO, or clinical research settings … Working knowledge of current CDISC standards — CDASH, SDTM, ADaM, define.xml· Track record of producing and validating submission-ready TFLs and datasets, including ad hoc analytical requests· Experience supporting regulatory submissions (FDA required; PMDA, NMPA, or EMA experience a plus)· Comfort working with external vendors and CRO-managed data ...