Minimum Requirements:
• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life
sciences required.
• A programming experience in industry recommended.
• For US positions: US military experience will be considered towards industry
experience.
• Demonstrated proficiency in using SAS, R or other programming languages to
produce derived analysis datasets and TFLs.
• Understanding of clinical data structure (e.g. CDISC standards) and relational
database.
• Demonstrated skills in using software tools and applications, e.g., MS office, XML.
• Demonstrated ability in the handling and processing of upstream data, e.g., multiple
data forms, workflow, eDC, SDTM.
• Demonstrated ability in providing outputs to meet downstream requirements,
e.g.,
ADaM, Data Definition Table, e-submission.
• Have valuable understanding of regulatory, industry, and technology standards and
requirements.
• Have valuable knowledge of statistical terminology, clinical tests, medical terminology
and protocol designs.
• Demonstrated ability to work in a team workplace with clinical team members.
Preferred Requirments:
• Minimum of 3 years clinical / statistical programming experience within
pharmaceutical clinical development
• Knowledge of the drug development process, clinical trial methodology, statistics