Job Description
Statistical Programmer role at Katalyst CRO .
Services rendered will adhere to applicable Pharmaceutical SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
Creation of other ancillary data streams including (but not limited to) clinical registry reporting files (e.g. Clintrials.gov, EudraCT), Bioresearch monitoring reports (BIMO).
QC of all programmed output.
Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA and other regulatory agencies as needed.
Includes support for standalone studies as well as integration of data across studies.
Provider Functional Manager, Pharmaceutical Point of Contact, Janssen project lead programmer.
Programming or biostatistics staff from partner contract research organizations (CRO's) in support of deliverables based outsourced projects.
Bachelor's degree with Minimum 4+ years of experience or higher and / or e...
Services rendered will adhere to applicable Pharmaceutical SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
Creation of other ancillary data streams including (but not limited to) clinical registry reporting files (e.g. Clintrials.gov, EudraCT), Bioresearch monitoring reports (BIMO).
QC of all programmed output.
Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA and other regulatory agencies as needed.
Includes support for standalone studies as well as integration of data across studies.
Provider Functional Manager, Pharmaceutical Point of Contact, Janssen project lead programmer.
Programming or biostatistics staff from partner contract research organizations (CRO's) in support of deliverables based outsourced projects.
Bachelor's degree with Minimum 4+ years of experience or higher and / or e...