May 9, 2018 – Senior Statistical Programmer – p Job SummarySr. Statistical Programmer will be responsible for supporting statistical programming activities for registrational and
April 16, 2018 – Senior Windows Engineer – p b Job Responsibilities: /b /p ul li Responsible for our Windows build machines within our Regulatory Clinical Solutions group. /li li Provide
April 16, 2018 – Senior Quality Engineer – p b Job Description: /b /p ul li Coordinate design Assurance activities in support of product development and life cycle processes between
April 16, 2018 – Senior Statistical Programmer – p b Job Responsibilities: /b /p ul li Provides statistical programming support for project. /li li Reviews protocols, CRFs, statistical
The Senior Statistical Programmer provides Statistical Programming technical leadership and support to team members. He/She delegates tasks appropriately and tracks progress.
The Senior Statistical Programmer may also construct estimates of project resource requirements and time lines and routinely briefs management on accomplishments, status of projects, and any issues.
In addition, the Senior Statistical Programmer is a designated member of clinical subteam(s) in the role of project lead Statistical Programmer for a limited number of studies.
Effectively designs and codes SAS programs for assigned project(s), consistently meeting objectives of the project
Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic submissions of data in CDlSC format with minimal instruction or input from supervisor
Provides guidance on the resolution of highly complex clinical trial reporting p
Primary Job Responsibilities:
Create and review (electronic) Case Report Forms perProtocol and annotated Case Report Forms
Review Protocols to ensure database feasibility
Develop/build, review, and maintain a clinical database andsupporting specifications documentation
Develop/build, document and perform validation of databasestructure, data capture screens, code lists, edit checks, reports and otherfunctions in EDC (e.g. User Acceptance Testing)
Develop data transfer agreements and specifications withvarious vendors
Write, review and maintain eCRF completion guidelines, datamanagement plan (DMP), data validation plan (DVP, e.g. edit checks), and otherDM related documentation
Perform all aspects of DM process as related to processingand QC of the data
Clean data for study close out and perform all database lockprocedures
The Principal Pharma Quality Engineer will provide quality assurance expertise for the development, site transfer, manufacturing and testing of combination medical device/drug products for the Fridley CRHF (Rice Creek) Pharmaceutical Operations business.
In this role, you would provide quality engineering support in sterilization management, environmental control, and cGMP pharmaceutical manufacturing of combination products including analytical lab activities. Provide support to internal and external customers, perform root cause analysis and implement corrective action. May manage projects for new or revised products or quality system changes in cGMP pharmaceutical requirement of combination products. Provides coaching on cGMP regulations and all relevant standards to Quality and Manufacturing Engineering staff. to staff.
CRHF seeks candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in o