The Senior Statistical Programmer is responsible for planning, managing and execution of statistical programming deliverables in clinical trial and non-trial activities in the project .
Responsible for providing input to authority required documents for the trial and non-trial activities .
Responsible for ensuring that clinical trial and non-trial tasks are aligned with the project specifications .
Responsible for continuous development of own skills and to contribute to the development of Biostatistics .
Responsible for planning, managing and execution of statistical programming deliverables in clinical trial and non-trial activities in the project .
Provide programming input to the setup of the trial, including but not limited to the CRF, Trial Validation Plan and Data Flow Plan .
Ensure that mock TFLs are created and reviewed by stakeholders .
Make AdaM programming according to industry standard and client specifications .
Ensure that programming, also by co-workers and functional suppliers, is done according to specifications .
Ensure that the inspection readiness documentation is updated at all times during the trial life cycle .
Responsible for providing input to authority required documents or meetings for trial and non-trial activities .
Create output and provide programming input to the Risk Management Plan, the Investigational Brochure as well as the DSUR/PSUR .
Ensure that relevant programming output and documentation is uploaded or made available for public disclosure, e.G. ClinicalTrials.Gov and EudraCT .
Provide programming input to submission related documents, e.G. BIMO, ADRG and summary documentation .
Contribute with programming input in the preparation for meetings with regulatory authorities .
Responsible for ensuring that clinical trial and non-trial tasks are aligned with the project specifications .
Responsible for creating and gathering input to the Specification ADRG for the clinical trial, and ensuring it is aligned with the Project ADRG .
Takes initiative and assists in solving and developing methodological or technically demanding tasks where innovation is a key element .
Continuously supervises and assists co-workers in the use of statistical programming technologies as well as development of new standards within the sub-project area globally .
Presents regularly at programming knowledge sharing meetings within the biostatistics area globally .
Able to explain technical issues to peers and align tasks with stakeholders.
Required Skills:
Minimum bachelor' s degree .
+5 years of statistical programming within the pharmaceutical industry .
At least 5 years of SAS programing in Pharma industry .
Familiar with SDTM (date format convention that FDA requires that data being
submitted as this format) .
Exp using standard MACRO' s .
Extensive experience with programming in e.G., SAS or R .
Experience with reporting clinical trials, including statistical data handling, analysis, and reporting .
Experience with review and documentation of programs .
Good knowledge of drug development .
Experience with clinical database technologies, data models and advanced programming .
Experience with collaboration across professional and regional borders .
Regular experience with communication and presentations .
In-depth knowledge of computer systems and IT .
Good knowledge of GxP and guidelines within drug development .
Some understanding of the pharmaceutical industry, with a focus on how to deliver on own goals .
This 12+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com
ALPHA' S REQUIREMENT #23-00549
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
