Your new role
Under general guidance, designs, develops, evaluates and modifies SAS (Statistical Analysis Software) or R programs to analyse and evaluate clinical data. Assesses data accuracy and consistency.
Under general supervision, programs using SAS/R Studio for statistical analysis and transfer of files or data to and from other databases.
Develop, review and quality control the TLFs and other reports necessary for clinical studies and study reports.
Coach and guide statistical programmers and collaborate with other statistical colleagues and study personnel to provide input to statistical analysis plans.
Develop, validate and maintain global tools such as SAS macros or R Shiny that increase the efficiency of the programming.
Work with clinical data and lead teams of programmers providing statistical and programming support to supplemental or exploratory analyses for regulatory agencies or any other ad-hoc requests.
Review outputs to ensure consistency across programs within study.
Validate, document and archive single-use programs as per department SOPs under proper guidance.
What you'll need to succeed
At least Master degree in Biostatistics, Statistics or a related field, PHD preferred.
Proficiency in English language skills.
Experience in analysis and reporting using SAS, R or other statistical software.
Understand pharmaceutical and/or medical device regulation and ICH/GCP.
Masters with at least 2 years of relevant experience or graduated PHD.
Experience with clinical study design preferred.
Experience in CNMPA submissions and in vitro diagnostic tests preferred.
Effective oral and written communication skills; able to get ideas across face-to-face, in group settings as well as in presentation.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1230865