Sr. Statistical ProgrammerKatalyst CRO • Summit, NJ, United States

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Sr. Statistical Programmer

Katalyst CRO • Summit, NJ, United States

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Join to apply for the Sr. Statistical Programmer role at Katalyst CRO .

3 days ago Be among the first 25 applicants.

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 to 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.

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 area being serviced.

Demonstrated understanding of current industry standards for submission of clinical trial data.

Job Details

Seniority level : Associate

Employment type : Contract

Job function : Information Technology

Industries : Pharmaceutical Manufacturing

Location : Summit, NJ

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