Sr. Statistical Programmer
4 weeks ago
Join to apply for the Sr. Statistical Programmer role at Katalyst CRO. 3 days ago Be among the first 25 applicants. Responsibilities You could be just the right applicant for this job Read all associated information and make sure to apply. 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 Referrals increase your chances of interviewing at Katalyst CRO by 2x. #J-18808-Ljbffr
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Sr. Statistical Programmer
3 weeks ago
Summit, United States Katalyst CRO Full timeJoin 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...
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Sr. Statistical Programmer
4 weeks ago
Summit, NJ, United States Katalyst CRO Full timeJoin to apply for the Sr. Statistical Programmer role at Katalyst CRO . 3 days ago Be among the first 25 applicants. Responsibilities You could be just the right applicant for this job Read all associated information and make sure to apply. Services rendered will adhere to applicable Pharmaceutical SOPs, WIs, policies, local regulatory requirements, ICH-GCP,...
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Sr. Statistical Programmer
6 days ago
Summit, NJ, United States Katalyst HealthCares & Life Sciences Full timeJob Title 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...
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Sr. Statistical Programmer
1 week ago
Summit, NJ, United States Katalyst HealthCares & Life Sciences Full timeJob Title 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...
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Sr. Statistical Programmer
3 weeks ago
Summit, United States Katalyst HealthCares & Life Sciences Full timeJob Title 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...
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Sr. Statistical Programmer
7 days ago
Summit, United States Katalyst HealthCares & Life Sciences Full timeJob Title 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...
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CNC Mill Setup/Operator
3 days ago
Lee's Summit, Missouri, United States SR Precision Holdings LLC Full time $60,000 - $120,000 per yearLooking to work daytime hours in a clean, modern, and supportive manufacturing environment? We are seeking a CNC Mill Setup Operator / Programmer to join our growing team on 1st Shift. This role is ideal for a skilled CNC Machinist/Programmer who can demonstrate proficiency in programming, setting up, and operating CNC Machining Centers or similar precision...
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Program Manager
4 days ago
Lee's Summit, Missouri, United States SR Precision Holdings LLC Full time $80,000 - $120,000 per yearUnitech Precision Machine, a recognized leader in the precision machining industry, is seeking a highly skilled and results-driven Program/ Account Manager to join our dynamic team. The ideal candidate should demonstrate both technical knowledge and leadership in managing precision machining projects from inception to completion. The position is embedded in...
