Senior Statistical Programmer
Date Posted: Monday, 13th of February 2012
Salary: Circa £40,000
Start Date: 12 Mar 2012
Telephone: +44(0)1438 870028
Location: South East UK
Consultant Name: Priya Mukherjee
Sector: Clinical
Description
CK Clinical is recruiting for a Senior Statistical Programmer who will provide technical expertise for the conduct of clinical trials, where you will act as an internal subject matter expert in specific areas, providing technical support and expert advice, and work independently to support various programming activities related to the analysis and reporting of clinical study data.
Key Accountabilities:
* Deliver best value and high quality service.
* 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 qualitycontrol (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/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 datalistings.
* Create standard macros and applications to improve the efficiency of the department.
* Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
* Proactively participate in and/or lead process/quality improvement initiatives.
* Work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/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.
Interested applicants should hold^a BSc Degree in a Life Sciences, Computer Science, Mathematics, Statistics OR Equivalent and should have previous proven experience of working in a Pharmaceutical/CRO/Biotechnology organisations. You will be a proficient user of SAS and hold knowledge of the programming and reporting process. You will be able to demonstrate ability to learn new systems and function in an evolving technical environment, with the ability to successfully work together within a team as well as independently.
CKClinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL23701 in all correspondence.
