Company: Worldwide Clinical Trials
Location: Nottingham or Homebased
Reference: JL BIOS17
Closing Date: 27 Apr 17
Type: Full Time
Salary (£): Competitive
Summary: Independently manages statistical project support and provides expert statistical consultancy across the stats function. The role can be tailored to the level of competency and experience you offer and, working in a multi-functional team environment, will give the job-holder wide exposure to the many aspects of drug development.
Office based Nottingham or Home based for an ideal candidate.
This is a career enhancing opportunity for a Senior Statistician to join an international Contract Research Organization and take their career to the next level.
Tasks may include but are not limited to:
* Manage the statistics support to one or more projects/sponsor programmes of work, ensuring that needs are fully met by expert and timely statistical consultancy and support.
* Provides expert review of study designs, analysis plans, and reports.
* Assist sponsors in the design of clinical trials, including statistical sections of the study protocol, randomisation methodology and writing statistical analysis plans.
* Liaise with internal departments, sponsors and other third parties regarding statistical issues and reporting requirements.
* Provide project support to the statistics reporting process through the specification/review of tables, figures, and listings shells, writing/review of derived dataset specifications and the formatting of report documents and tabulations.
* Undertake the preparation of final reports, including the production of tables, listings, and figures, and report writing.
* Develop, test and run SAS programs for the statistical analysis and reporting of clinical study data. This includes programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings and their validation.
* Ensure the maintenance of documentation e.g. the description of programs and validation
* Produce ad hoc data summaries when requested during the course of a trial.
* Extract information from the system during the course of a trial e.g. summaries, data listings, study data sets.
* Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation.
* Make statistical contributions to manuscripts for publication/presentation.
* Provide support for the bidding process, including contribution to budget review, proposals, and bid defense meetings.
* Lead identifying system and process improvements, and develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting.
* Support the development of statistical design and analysis policies.
* Maintain knowledge in design consultancy and analysis methodology, statistical software packages (e.g. SAS and nQuery) and regulatory guidance documents e.g ICH, FDA and CPMP points to consider.
* Assist with Quality Assurance and Audit requirements.
* Assist the Director of Biostatistics with all other aspects of the job as required.
* Perform all activities in compliance with WCT and agreed sponsor quality system standards, relevant ICH standards and specifically with FDA Quality System Regulation (including 21CFR Part 11).
Desired Skills and Experience
* Educated to degree level in mathematics, statistics or another subject with a strong statistical component.
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, the level of responsibility, and ability to work independently.
OTHER SKILLS AND ABILITIES:
* The job holder must be computer literate and numerate with a proven ability to adapt to various computer systems
* Hands-on expert level project statistician experienced in providing statistical leadership to projects.
* Design and analysis consultancy skills and knowledge across a broad range of applications together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change.
Due to the volume of applications, we regret that we can only respond to successful candidates.
Worldwide Clinical Trials is a global CRO providing full-service drug development services to the pharmaceutical and biotechnology industries from Early Phase and Bioanalytical Sciences through Phase II and III trials to peri-approval studies.
Our team offers clients a wealth of expertise in CNS, cardiovascular, oncology, and other therapeutic areas.
We successfully manage clinical trials with our own staff across nearly 60 countries in North America, Latin America, Europe, Asia-Pacific and the Middle East.
Worldwide Clinical Trials, does not accept unsolicited calls and unsolicited resumes from third-party recruiters or agencies. Any third-party resumes forwarded by recruiters to WCT or to any of our employees will be considered public information, may be treated as a direct application from the person identified in the resume, and will not be eligible for placement fee payment to the agency.
All inquiries about this vacancy should be directed to:
MOB: +44 7810 117 240
Worldwide Clinical Trials
2nd Floor 172 Tottenham Court Road London
|Tel:||0207 121 61 61|
|Website:||Visit Our Web Site|
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