JB
Send me an email View LinkedIn profile OAKHAM United Kingdom LE15 7HL
With over 25 years experience within the Pharmaceutical Industry, providing expert statistical services and advice, Sigma Statistical Solutions offers an extensive range of options to deliver a top quality service to meet your needs. Driven by quality, timelines and a focus on customer requirements, we aim to work in partnership with clients to deliver the right solution to meet their needs. Whether it be a large complex project, a need for additional statistical resource to cover short term requirements or the analysis of a specific data set then Sigma Statistical Solutions is the choice for you. To see the wide range of services we offer and the previous experience, please browse our web site www.sigma-stats.com or contact us on 07747 882983 for further information.
Pharmaceutical Industry Experience Preparation of integrated summaries for efficacy (ISE) and safety (ISS) of data from a complex program of randomised and uncontrolled studies in an oncology indication. Expert statistical input to the development and delivery of high quality funding applications for clinical trials and other high-quality studies. Leadership of technical functions and provision of statistical programming support for drug submissions and regulatory defence. Provision of Statistics support for drug submissions. Lead Project Statistician for Oncology Product in Phase III development. Provision of all aspects of Data Management for regulatory authorities in both Europe and the USA through all phases of Clinical Research. Leadership and management of Statisticians and Data Managers. Design and analysis of Clinical Trials. Design, analysis and reporting of Clinical Trials in the Areas of Asthma, Rheumatism, Pain and Oncology, leading to successful regulatory submissions.
Pharmaceutical Industry Services:- Statistical contribution to the design, implementation, analysis and reporting of clinical trials. Working according to ICH E9 Statistical Contributions to Clinical Trials. Statistical Design of Clinical Trials. Protocol writing of Statistical Sections. Sample size calculations. Preparation of Statistical Analysis Plans. Data Analysis and Statistical Report Writing. Management and oversight of Statistical work performed by CROs. Preparation and review of Statistical Standard Operating Procedures (SOPs). Legal Services:- Analysis of complex data sets, event likelihood analysis. Provision of expert evidence. Forensic evidence analysis.