Biostatistics

Study Design & Statistical Planning

Study-level statistical strategy from protocol design through data-collection planning.

• Statistical input to Phase I–IV clinical trial protocols
• Study design evaluation and statistical justification
• Endpoint selection and statistical strategy
• Sample size and power calculations
• Randomization design and allocation methodology
• Statistical input to analysis populations and assessment schedules
• Statistical review of Case Report Forms (CRFs), data-collection requirements and analysis-related study documents

Statistical Analysis Planning

Detailed planning of estimands, analyses, populations and presentation shells before database lock.

• Development and review of Statistical Analysis Plans (SAPs)
• Development of mock tables, listings and figures (TLFs)
• Estimand strategy aligned with ICH E9(R1)
• Missing-data handling and sensitivity-analysis strategy
• Multiplicity and multiple-endpoint considerations
• Definition of analysis populations and derived endpoints
• Subgroup, exploratory and supportive-analysis planning

Study Statistician Support

Senior statistical involvement throughout study planning, conduct, analysis and sponsor interactions.

• Senior statistical oversight throughout study planning, conduct and analysis
• Randomization scheme development and implementation support
• Statistical support for protocol amendments and analysis-impact assessments
• Blinded data review and statistical input before database lock, where applicable
• Statistical participation in sponsor and cross-functional study-team meetings
• Statistical participation in regulatory interactions, where required

Interim Analysis & DMC/DSMB Support

Statistical planning, outputs and committee support for interim and independent monitoring activities.

• Interim analysis planning and execution
• Preparation and validation of interim datasets and TLFs
• Statistical support for Data Monitoring Committee/Data Safety Monitoring Board (DMC/DSMB) meetings
• Open and closed DMC/DSMB reporting packages, where applicable
• Safety and efficacy summary outputs for committee review
• Statistical support for endpoint adjudication committees, where applicable
• Statistical outputs supporting periodic safety reporting, including the Development Safety Update Report (DSUR), where required

Efficacy, Safety & Integrated Analyses

Study-level and cross-study analyses covering primary endpoints, safety, robustness and integrated summaries.

• Primary and secondary efficacy endpoint analyses
• Safety and tolerability analyses
• Demographic and baseline-characteristic summaries
• Longitudinal and repeated-measures analyses
• Time-to-event and categorical endpoint analyses, where applicable
• Subgroup, sensitivity and robustness analyses
• Missing-data analyses
• Integrated Summary of Safety (ISS) support
• Integrated Summary of Effectiveness (ISE) support
• Cross-study and pooled analyses
• Meta-analysis, where applicable

Statistical Reporting & Regulatory Support

Submission-oriented statistical deliverables, interpretation and support during regulatory review.

• Analysis datasets and tables, listings and figures
• Statistical report writing
• Statistical methodology and results sections of the Clinical Study Report (CSR)
• Statistical interpretation and presentation of study results
• CDISC-compliant SDTM and ADaM datasets, with independent QC and validation of statistical outputs
• Statistical support for global regulatory submission documents
• Responses to regulatory authority statistical questions
• Additional, sensitivity and supportive analyses