Principal Statistical Programmer Freelancer - Home Office

Deutschland  ‐ Vor Ort
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Schlagworte

Beschreibung

Job Description:
The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical Programming Coordinator role on projects, and liaise with sponsors, Data Operations Leads, and other functional areas as required.

* Deliver best value and high quality service.
* Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming Coordinator will:
* Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
* Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
* Monitor project resourcing, project budgets, and identify changes in scope.
* Interact with Sponsors as the key contact with regard to statistical programming issues.
* Provide technical support and advice to the internal team.

* Check own work in an ongoing way to ensure first-time quality.
* Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
* Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g. setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
* Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents.
* Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings.
* Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department.
* Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units.
* Create standard macros and applications to improve the efficiency of the department.
* Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
* Be trained in sponsor SOP's and disseminate knowledge to project team members as appropriate.
* Proactively participate in and/or lead process/quality improvement initiatives.
* Work closely with the Quality Management Groups (QMG) to ensure compliance with SOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required.
* Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.
* Maintain and expand local and international regulatory knowledge within the clinical industry.
* Assist project teams in the resolution of problems encountered in the conduct of their daily work
* Provide relevant training and mentorship to staff and project teams.

Start Date: asap
Interviewslots: asap
Hourly rate: depending on experience

Please send me your CV asap if you are interested in this role!

Have a nice evening & kind regards,
Carla Störzer
Start
08/2014
Dauer
6 Monate
Von
Progressive Recruitment
Eingestellt
08.08.2014
Projekt-ID:
755266
Vertragsart
Freiberuflich
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