Priya Mukherjee at CK Clinical is currently recruiting for a Principal Statistical SAS Programmer to join a Clinical Research Organisation based in the South East UK.
Principal Statistical SAS Programmer Job Description:
As Principal Statistical SAS Programmer you will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors. In addition, the Principal Statistical Programmer can fill the Statistical Programming Coordinator role on projects; liaise with sponsors, Data Operations Leads, and other functional areas as required. Further, the Principal Statistical Programmer will monitor quality, timelines, resource allocation and productivity in relation to budgets.
Further responsibilities of this Principal Statistical SAS Programmer position will include:
- Deliver best value and high quality service.
- 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, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
- Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
- Be trained in sponsor WSOP’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 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 areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, SQL, and other programming language usage 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 broad support, including advice on new technologies and industry technical standards (e.g., EDC, CDISC, Statistical principles, CFR Part 11, electronic submissions, applications and communications technologies, etc.) and their integration into Programming processes.
- Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.
- Provide consultancy to internal and external sponsors with regard to statistical programming tasks. In addition, maintain visibility to these sponsors to ensure expectations are being met and that requirements are accurately distributed to the appropriate stakeholders.
- Provide oversight and guidance on multiple-trial programs, complex trials, and submission projects (including Integrated Summary of Safety or Efficacy).
- 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.
- Create standard macros and applications to improve the efficiency of the department.
- Assessment of technology and processes,to facilitate best practices, increase quality, efficiency, and productivity.
- Consult with sponsors on technical/regulatory issues.
- Represent Statistical Programming on cross-functional technical initiatives.
As Principal Statistical SAS Programmer you will have the following qualifications, skills and experience:
- Degree level in a relevant subject, including Life Sciences, Mathematics, Computer Sciences, Statistics OR Equivalent.
- You will also be proficient in SAS, and hold knowledge of the programming and reporting process.
- You will be able to demonstrate the application of CRS concepts to achieve best practice and promote continuous improvement, together with the ability to learn new systems and function in an evolving technical environment.
- You will hold strong leadership ability and Business/Operational skills that include customer focus, commitment to quality management and problem solving.
- You will have excellent analytical skills, good presentation skills and the tenacity to work in an innovative environment.
- You will also be able to demonstrate the ability to negotiate and influence in order to achieve results.
How to apply:
For more information regarding this Principal Statistical SAS Programmer position, please contact Priya Mukherjee on +44(0)1438 870028 or email firstname.lastname@example.org.