Kinetic PLC are currently seeking a Senior Manager / R&D Programmer to join a busy Pharmaceutical Manufacturing Company, based within the Harlow, Essex area.
Duration: 2 years from Start
Annual Salary: approx £56,(Apply online only)% Remote - will access systems via your own laptop - VDI connection)
25 Days Annual Leave (pro rata plus Bank Holidays)
Position Summary:
The Clinical Programming (Contractor) is responsible for providing comprehensive programming support, including managing the timely and accurate execution of programming components of clinical trials.
The clinical programming contractor independently manages completed projects that involve global tasks, or cross functional teams The role may require providing inputs to design and analysis, and reporting the results of clinical trials, including programming rules and mocked T/L/G. In addition, providing programming support for publication for our marketed drugs.
Essential Duties & Responsibilities:
Primarily works at the Study, product / program level
Provides comprehensive programming support, including development of programs, ADaM specifications, analysis (datasets, TLFs) complying with regulatory requirements, departmental SOPs and work practices.
Manages and Delivers assignments with good quality and within timelines
Provides programming support to CDISC based e-submission. Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets and TLFs.
Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate to management on project status and resource gaps.
Responsible for the standardization of GSD deliverables (TLGs, Datasets) across study projects within an indication/therapeutic area. Provides input on opportunities for process improvement
Proactively communicates issues impacting programming deliverables with Stat or DM team members.
Education Required:
* Bachelor's Degree/Master's Degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
Experience Required:
* Bachelors + 5 year, Masters + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer.
* Proficient knowledge of clinical trials and drug development process, industry standards, statistical concepts used in analysis and submissions of clinical trial data.
* Strong understanding of SDTM, ADaM standards and Implementation guides.
* Demonstrated proficiency in using SAS to produce analysis datasets, TLFs, eSUB components and using other software applications (eg. Pinnacle 21, XML and MS Office)
* Demonstrated ability to work independently and in a team environment.
Functional Knowledge:
* Expert level of programming skills and problem resolution in SAS.
* Expert level of knowledge in CDISC based e-submission (creation of ADaM datasets and associated TLGs in study/project (e.g. ISS/ISE), creation of Bioresearch Monitoring (BIMO) Inspections).
* Have solid knowledge of statistical models used for efficacy data analysis.
Company/Industry Related Knowledge:
* Advanced knowledge of government regulations (such as CDISC and ICH) pertaining to drug development in multiple therapeutic areas.
Job-Specific Competencies:
1. Tackles difficult problems; identifies solutions and recommends action management
2. Influences communication toward common understanding and actionable results;
3. Good oral and written communication skills.
If you feel that you have what we need, then please call Sophie on (phone number removed) or email your up to date CV to: (url removed)
Kinetic plc is a Recruitment Consultancy with over 40 years of experience of delivering staffing solutions to the engineering, manufacturing and technical industries.
Kinetic plc treats all applications with a high degree of care, we review all submissions and will attempt to contact applicants who match the job profile. Those that do not meet the specification may not be contacted but their CV retained to be considered against future opportunities.
Kinetic Recruitment Services Ltd operates as an Employment Business and Recruitment Agency as defined under the Employment Agencies Act 1973.
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