Bachelor's degree in computer science, mathematics, or a related scientific field.
Minimum 4+ years of experience in programming or biostatistics, ideally within a CRO context.
Proficiency with SAS (Base and Macro) for clinical trial data analysis.
Strong written and verbal communication skills.
Ability to work remotely and manage projects independently.
Familiarity with clinical trial data including study population and efficacy parameters.
Understanding of current industry submission standards for clinical trial data.
Responsibilities
Ensure compliance with Pharmaceutical SOPs, WIs, and local regulatory requirements.
Create ADaM datasets following established standards.
Generate Tables, Listings, and Figures according to Janssen specifications.
Develop Subject Narratives using pre-defined Janssen templates.
Produce ancillary data reports and clinical registry files.
Perform quality control on all programmed outputs.
Document specifications for data processing and analysis.
Support regulatory electronic submissions to agencies like the FDA and EMEA.
Assist in standalone studies and data integration across projects.
Benefits
Opportunity to support innovative clinical research initiatives.
Work within a collaborative environment with leading industry professionals.
Flexible remote work arrangements.
Access to continued professional development in biostatistics and data analysis.
Engagement in diverse therapeutic areas enhancing skill diversification.
Full Job Description
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 (e.g. Clintrials.gov, 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.
Requirements:
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 equivalent in computer science, mathematics or other scientific field (or equivalent theoretical/technical depth).
Demonstrated written and verbal communication.
bility 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.
