Sr. Statistical ProgrammerKatalyst HealthCares & Life Sciences • Summit, NJ
Sr. Statistical Programmer
Katalyst HealthCares & Life Sciences • Summit, NJ
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]
Responsibilities:
Responsibilities:
- Services rendered will adhere to applicable Pharmaceutical SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
- Creation of ADaM datasets based on current ADaM standards.
- Creation of Tables, Listings and Figures following Janssen specifications.
- Creation of Subject Narratives following Janssen templates too support Narrative development.
- Creation of other ancillary data streams including (but not limited to) clinical registry reporting files ( , EudraCT), Bioresearch monitoring reports (BIMO).
- QC of all programmed output.
- Creation and/or maintenance of detailed specification documentation.
- 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.
- Primary interfaces: 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 + years of experience or higher and / or equivalent in computer science, mathematics or other scientific field (or equivalent theoretical/technical depth).
- Demonstrated written and verbal communication.
- Ability to work remotely.
- High level experience in the implementation of SAS (Base and Macro) in the analysis of clinical trial data.
- Working knowledge of clinical trial data (Study population, safety, efficacy, PK/PD) in the therapeutic are being serviced.
- Demonstrated understanding of current industry standards for submission of clinical trial data.
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