Statistics and Programming

In accordance with ICH (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use) Good Clinical Practices (GCP) or other GXP such as Good Manufacturing Practices (GMP), other international guidelines (e.g. ISO), working group recommendations (e.g. CDISC or Good Programming Practices), and respecting deadlines, quality, regulatory requirements.

Statistics capabilities

• Input in study design , sample size or power calculations Statistical section of any study document (eg, protocol, study report)
• Randomization  Statistical review of study documents (eg, Case Report Form, protocol, study risk management plan, IRT specifications, study report…)
• Statistical analysis plans , including shell TL&Fs (Tables, Listings and Figures) 
• Data Monitoring Committee (DMC):  charter, SAP, shell TLFs
• Conduct and interpretation of statistical analysis
• Meta-analyses
• Statistical report
• Clinical Study report
• Trial disclosure
• Statistical support to Market Access (Review of Payer documents,  Preparation of Payer AdBoard,  statistical support for internal decision making)
• Regulatory agency discussions Support for publications, abstracts , posters, manuscripts

Programming capabilities

• Review of study/project documents (eg, Case Report Form, Statistical Analysis Plan, Protocol…).
• Development and validation of derived datasets (SDTM, ADaM CDISC format, legacy, pools)
• Development of documentation: specifications (Metadata file, define.xml, cSDRG, ADRG, ARM)
• Validation of datasets, Define.xml by using QC and Pinnacle 21
• Programs in SAS, R, RShiny to meet the study / project needs
• Statistical outputs: tables, listings, figures
• Package for submission (FDA, EMA,..)
• Complementary analyses to support HTA (Health Technology Assessment) submission