Overview: This position will support Data Management, Medical Affairs and Statistics. This
person will work closely with Crescendo team members in accordance with company SOPs,
FDA, & ICH guidelines and regulations.
Principal Responsibilities:
Responsibilities include supporting all Crescendo clinical study activities by supporting:
? Provide datasets, tables, listings, and figures for clinical study reports, research, and
product development.
? Merge data and perform cross-sectional queries
? Generate programs/scripts to assist with:
o Data processing
o Data QC/QA
o Edit checks
o Improve efficiencies and minimize potential for error reporting.
o Managing laboratory sample and clinical data
? Generate data sets can be provided to outside collaborators
? Assist with planning, designing, validating, and documenting clinical databases.
? Design, develop, and modify SAS programs to store, analyze and evaluate clinical and
research data.
? Query legacy data
Requirements:
? Experience in SAS (including SAS Base/Macro/SQL/STAT/Graph). SAS certification a plus.
? Bachelor degree or above in statistics, mathematics, or computer science or a degree in
biological sciences with 2 or more years of SAS programming experience
? Minimum of 4 years of experience in the biotech, diagnostic, and/or pharmaceutical
industries? Must have excellent communication skills with the ability to interface effectively with
management and interdisciplinary project teams both verbally and in writing.
? Ability to work independently as well as part of a multi-disciplinary team.
? Ability to adapt to rapidly changing demands of a fast paced and novel start-up
environment
? Experience producing deliverables for regulatory submissions using SAS (analysis
datasets, tables, listings, graphs) and/or clinical trial databases is desirable.
? Knowledge of additional languages and software (R, Python, Perl, etc.) is a plus.
? Experience with clinical trials preferred.
? Ability to multi-task