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HomeStatistical Analyst
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Freelance Statistical Analyst Birkenhead, Merseyside, UK

Doctor in Neuroscience (PhD),12 yrs experience Statistics (SPSS), Protocols & Reports, Data Management, Quality affairs, Management of Clinical Projects, Healthcare Projects, Journalism, Translations.

Rating:5 out of 5 (4 reviews)
Hourly Rate / Cost:£47.06 per hour (ex. VAT)
Daily Rate / Cost:£376.47 per day (ex. VAT)
Available From:Now
Candidate ID:242841

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[ Top | Ratings | CV | Skills ]

Ratings

  Excellent
02 February 2009: Silvia is extremely skilled at what she does; I found her very approachable if there was any query and always delived on time.

  Excellent
03 December 2008: Silvia was a real asset; the service she provided was both professional, accurate and timely. I would have no reservations in recommending Silvia to any potential buyers.

  Excellent
24 October 2008: I had no issues; found dealing with her very direct and professional. I was kept in the picture during the assignment and would certainly recommend Silvia.

  Excellent
16 April 2008: Silvia has provided an excellent analysis. She met a very tight deadline, and responded exceptionally quickly to my emails. Many thanks to Silvia for a great job.

[ Top | Ratings | CV | Skills ]

CV (Curriculum Vitae) / Résumé

• +11 years’ experience in Clinical Research and 12 years' in Statistical Analysis and Reporting.
• Technical innovation and development of procedures (cognitive insights, quality of life, statistical analysis, etc). Client/user oriented.
• Management/Collaborations in European studies with emphasis on planning and execution of projects with a core function in identification of potential and actual issues with impact on successfully delivery of projects, ensuring solutions are implemented to prevent extension to timelines/budget or reduction of targets and quality.
• Analysis, interpretation and preparation of data for presentation at scientific meetings.
• Writing and submitting material for publication as abstracts and full papers to peer reviewed journals, reports and protocols.
• Training members of staff.
• High level of knowledge of International Conference on Harmonisation (ICH), Good Clinical Practice (GCP), Good Manufacture Practice (GMP), GxP, EU Directive and other Regulatory guidelines.
• Health & Safety Representative.
• Fully Certified Lead Investigator into major and critical deviations.

---------------
FREELANCE:

• Statistical analyses for commercial and scientific projects.
• Strategic business and scientific advice to clients and teams, developing key scientific messages.

RESEARCH MANAGEMENT:

• Management of the setting up, running, data collection and reporting of UK Trials and submissions.
• Management of electronic databases and statistical analyses, reporting and public dissemination of results via scientific publications and public media.
• Development of cost-effective health economics business models, proposals and reports for clients and NHS services through reviewing and analysing their requirements (business intelligence), developing key scientific messages.
• Management of design and communication plans writing, working closely with healthcare services clients to deliver projects.
• Support of operational plans and decisions of the Board of Directors to develop sustainable strategic planning in terms of human, logistic and financial resources and ultimately increasing the current portfolio of clients to meet targets and responsible for building lasting relationships with clients and company teams.
• Management and support of improvements in design and media communications at healthcare websites.
• Management of client and healthcare users’ feedback including risk assessments, questionnaires and quotations for commercial campaigns.
• Mentoring of research staff and team members. Meeting leader for design and development of new strategies.

QUALITY:

• Co-ordination of the setting up, running and reporting of the Stability Programmes for Europe and US products.
• Liaison with different laboratories and co-ordination of a variety of teams to provide consistency of the routine and technical studies as well as clinical trials.
• Quality Control of the GMP - Regulatory documentation related to Stability Studies, including SOPs, production of reports, protocols and deviation reports using the appropriate techniques of statistical analysis.
• Co-ordination of companies’ inspections, self-inspection audits and MHRA audits, ensuring that the systems are fit for purpose.
• Working closely with the GMP and QA team to ensure a consistency of systems approach between the two activities.
• Review and advice on Clinical Data Bases for the Clinical Trials.
• Control of all GCP - Regulatory documentation related to Clinical Trial studies in the company.

CLINICAL TRIALS:

• Document translations and contacting of European sites.
• Co-ordination of the setting up, running and reporting of Clinical Trials on the Validation and reliability of the Spanish version of the DN4 questionnaire.
• Patient Selection and Recruitment, Psychological and Neurological examination and questionnaires. Supervising patients’ medication from the clinical records and interviews.
• Supervision and co-ordination of the clinical reports and presentations for publishing.
• Conducted and controlled main studies from handover to completion; Monitoring nation-wide clinical trials and associated institutions and areas (co-ordination with Pfizer, Cajal Institute (Madrid), SESCAM (Castilla La Mancha), Hospital Clinic (Barcelona), and University of Valencia). Projects: 4 years maximum to completion (target was exceeded).
• Assisting in the updating and maintenance of the SOP system to ensure maintained compliance with GCP and European regulatory guidelines and legislation, and improving laboratory effectiveness, estimating costs of projects, trials, and record spends during projects.
• Production of Clinical Trial Plans, Protocols, CRFs, questionnaires for the patients and all the needed trial related paperwork, including the internal/ external approvals.
• Pharmacovigilance (clinical records, interviews; including Psychiatric pharmacy).
• Data Management, Statistical Data Analysis and Interpretation.
• Writing and co-ordinating the clinical findings and presentations for publishing (Cajal Institute (Madrid), SESCAM (Castilla La Mancha), Hospital Clinic (Barcelona), University of Valencia, Pain Relief Foundation, Aintree Hospitals, (Liverpool)).
• Mentored and trained of contracted and site staff in the Foundation and Hospital and visitor institutions within ICH / GCP guidelines, and trial related processes and procedures (physicians, doctors, nurses and students), provided assistance and advice on clinical staff recruitment.
• Clinical Psychologist at the Pain Unit and Spasticity Clinic in the Hospital.
• Techniques/ medical devices developed in Clinical Pain Diagnostics: VAS, VDS, and Quality of Life Questionnaires: MPI-SCI, CSQ. Pain Psychophysics: Bedside Sensory Testing, Quantitative Sensory Testing (QST), Thermal stimulation and Psychophysics. Laboratory pain tests with animals (von Freys, Hot Plate, Labyrinths, etc).

Employment History

(Mar 2011 to Nov 2012)

Manager of Research & Communications

UK

• Management of the setting up, running, data collection and reporting of UK Trials and submissions.
• Management of electronic databases and statistical analyses, reporting and public dissemination of results via scientific publications and public media.
• Development of cost-effective health economics business models, proposals and reports for clients and NHS services through reviewing and analysing their requirements (business intelligence), developing key scientific messages.
• Management of design and communication plans writing, working closely with healthcare services clients to deliver projects.
• Support of operational plans and decisions of the Board of Directors to develop sustainable strategic planning in terms of human, logistic and financial resources and ultimately increasing the current portfolio of clients to meet targets and responsible for building lasting relationships with clients and company teams.
• Management and support of improvements in design and media communications at healthcare websites.
• Management of client and healthcare users’ feedback including risk assessments, questionnaires and quotations for commercial campaigns.
• Mentoring of research staff and team members. Meeting leader for design and development of new strategies.
• Winners of 2012 E-Health Insider Awards (EHI) for ‘Best use of social media in healthcare’.


(Aug 2006 to Nov 2012)

Freelance independent consultant

UK

• Statistical analyses and reporting for commercial and scientific research projects.
• Strategic business and scientific advice to clients and teams, developing key scientific messages.


(Aug 2006 to Nov 2012)

Consultant - Statistics, Healthcare, Pharma

UK

• Statistical analyses and reporting for commercial and scientific projects.
• Strategic business and scientific advice to clients and teams, developing key scientific messages.


(Nov 2007 to Mar 2011)

Consultant & Quality Control Coordinator

UK

• Co-ordination of the setting up, running and reporting of the Annual Stability Programme for European and US products according to cGLP, cGMP, Health & safety, SOPs and environmental and regulatory requirements.
• Liaison with different laboratories and co-ordination of a variety of teams to provide consistency of the routine and technical studies as well as clinical trials; consumer oriented.
• Management of Quality Control– Completion of QC and Regulatory documentation related to Stability Studies, including SOPs, production of reports, protocols and deviation reports using the appropriate techniques of statistical analysis.
• Internal audits of methods, validation procedures and products. International patient information leaflet review according to Regulatory requirements.
• Provision of training and guidance to other members of the department.
• Fully Certified Lead Investigator in Root Cause Analysis for major and critical deviations.
• Health and Safety representative of the Department.


(Nov 2006 to Oct 2007)

Clinical Trials Advisor

UK

• Co-ordination of companies’ inspections, self-inspection audits and MHRA audits, ensuring that the systems are fit for purpose.
• Working closely with the GMP and QA team to ensure a consistency of systems approach between the two activities.
• Review and advice on Clinical Data Bases for the Clinical Trials.
• Management of GCP and Regulatory documentation related to Clinical Trial studies.
• Document translation and contacting of European sites.
• Jan 2007: Attended Course on UK Regulation of GCP, Ethics, MHRA Inspection, Trial Master Files; by the Association of Clinical Research Professionals (ACRP)


(Feb 2003 to Aug 2006)

Clinical Researcher

Spain

• Set-up the first clinical research laboratory in the hospital and monitoring of internal and external clinical trials conducted within a comprehensive knowledge of ICH/GCP.
• Conducted and controlled main studies from handover to completion; Monitoring nation-wide clinical trials and associated institutions and areas (co-ordination with Pfizer, Cajal Institute (Madrid), SESCAM (Castilla La Mancha), Hospital Clinic (Barcelona), and University of Valencia). Projects: 4 years maximum to completion (target was exceeded). Number of patients: 100.
• Assisting in the updating and maintenance of the SOP system to ensure maintained compliance with GCP and European regulatory guidelines and legislation, and improving laboratory effectiveness, estimating costs of projects, trials, and record spends during projects.
• Production of Clinical Trial Plans, Protocols, CRFs, questionnaires for the patients and all the needed trial related paperwork, including the internal/ external approvals.
• Pharmacovigilance (clinical records, interviews; including Psychiatric pharmacy).
• Data Management, Statistical Data Analysis and Interpretation.
• Writing and co-ordinating the clinical findings and presentations for publishing (Cajal Institute (Madrid), SESCAM (Castilla La Mancha), Hospital Clinic (Barcelona), University of Valencia, Pain Relief Foundation, Aintree Hospitals, (Liverpool)).
• Mentored and trained of contracted and site staff in the Foundation and Hospital and visitor institutions within ICH / GCP guidelines, and trial related processes and procedures (physicians, doctors, nurses and students), provided assistance and advice on clinical staff recruitment.
• Clinical Psychologist at the Pain Unit and Spasticity Clinic in the Hospital.


(Jul 2004 to Sep 2005)

Clinical Researcher

Research Foundation & NHS , UK

• Statistical analysis with SPSS (Non Parametric Analysis, ANOVAs, Correlations) and interpretation of results for publications.

Professional Qualifications

EDUCATION

• European Ph.D. (2006): Psychology-Neuroscience “Neuropathic Pain in Spinal Cord Injury Patients”. Rey Juan Carlos University (Madrid, Spain). 4-year Research Fellowship awarded (from the Spanish Health Authority, Ref.: IE02005).

• Advanced Studies Diploma (DEA) (2005): “Pain: Basic and Clinical Aspects”. Rey Juan Carlos University (Madrid, Spain).

• Bachelor Degree in Psychology B.Sc. (First Class Honours) (2002): Faculty of Psychology - Distance Education National University (Madrid, Spain). UK NARIC confirmation of Degree Comparable to British Bachelor (Honours) degree standard.


COMPUTING SKILLS

• Computer literate with an excellent working knowledge of the MS Office package and Statistical and Scientific programs (SPSS, SAS, Stata, Sigmaplot, Sigmastat, Spike, Chart 4, Scope, Reference Manager, Citrix - LIMS, Crystal reports, ATLAS, Sentry, ASM), Electronic Document Management Systems (EDMS), Livelink, Learning Management System (LMS). Web page consultant.


SCIENTIFIC MEMBERSHIP

- Member of the British Psychological Society (BPS) since 2009.
- Member of the Federation of European Neuroscience Societies (FENS) from 2005-2006.
- Member of the Spanish Neuroscience Society (SENC) from 2005-2006.


INTERNET GROUP MEMBERSHIP

- Member of ideaconnection website - access innovation (external consultancy) since 2012.
- Member of discussion forums: Quality and Regulatory, Network, Social Media for Business, Professionals in the Pharmaceutical and Biotech industry, International Behavioural Neuroscience Society, and others.


Education

(Nov 2003 to Jul 2005)

Rey Juan Carlos University

Advanced Studies Diploma (DEA) in “Pain: Basic and Clinical Aspects”, obtained as completed the 2nd year of PhD studies.


(Nov 2003 to Jun 2006)

Rey Juan Carlos University

European PhD in Neuroscience: “Neuropathic Pain in Spinal Cord Injury Patients”.


(Oct 1995 to Jun 2002)

Faculty of Psychology - Distance Education National University

Bachelor Degree in Psychology. UK NARIC confirmation of Degree Comparable to British Bachelor (Honours) degree standard.

Researcher,Stats,Psychology

Assignment History

(This Candidate has recently been shortlisted or contracted for the following people4 assignments)

  • SPSS Analyst: SPSS - Urgent requirement Need help running SPSS analyses on research data in psychology, topic as indicated upon contact. Will be around 5 hours work, to be completed asap and ideally this week. Please get in touch with Alexis Taylor - at@people4.com
  • SPSS Weighting: Contractor required to work on SPSS and demographic weighting of a sample. About three hours' work. Will send through work and information on weighting requirements.
  • Statistical analysis: Urgent analysis of survey statistics using Survey Monkey. Deadline of 17th May for delivery Further details to be confirmed to applicants.
  • SPSS Analysis: Data analysis of of psychology research using SPSS
  • SPSS Analyst: SPSS analysis and report on already collected data. Please contact me as soon as possible

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