Senior Statistical Programmer
C
Compass PathwaysBiotechnology
United Kingdom home basedContractSenior
Salary not disclosed
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Job Details
- Experience
- Extensive years experience
- Required Skills
- R
Requirements
- Extensive years experience in statistical programming
- CDISC expertise
- Proficient in programming including performing statistical analyses and creating macros in SAS, preferably R
- Programming/reporting expertise across all phases of clinical development (efficacy/safety/PK), including ISS/ISE reporting
- Experience in performing quality control (QC) checks
- Extensive knowledge in regulatory submission process
- Good understanding of ICH guidelines and regulations such as 21 CFR Part 11
- Experience supporting NDA submissions e.g., FDA, EMA, MHRA and addressing regulatory question
- Ability to solve challenging problems and provide recommendations to mitigate risk
- Good communication skills - both written and verbal
- Team work skills - Including cross-functional and within the Statistics and Data Management Team
Responsibilities
- Leading and coordinating the programming activities within agreed timelines
- Managing the reporting of studies internally and externally
- Programming outputs as stated in the analysis plan
- Working closely with study team members, mainly with the study statistician
- Reviewing of the Statistical Analysis Plan (SAP) and shells
- Create and review SDTM and ADaM study specifications
- Ensure programs, datasets, outputs are appropriate for regulatory submission
- Perform simulations, data modelling and interim analyses
- Liaise with external vendors on deliverables
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