KEY CURRENT JOB RESPONSIBILITIES:Lead teams of statisticians and collaborate with representatives from various functions to ensure the application of suitable and effective statistical analysis methods throughout the drug development process. Ensuring compliance with pertinent global and regional standards, procedures, and regulatory guidelines for regulatory submissions.Participated in rapid due diligence review of promising drug candidates for potential licensing, drawing on available data to assess portfolio fit for development.SAS AND R EXPERIENCE IN DATA ANALYSIS:•Developing simulations in R to test hypotheses and explore scenarios.•Applying statistical methodology for joint modeling of longitudinal and time to event data.•Perform power calculations using R, SAS, PASS, nQuery, and Addplan-Neo. OTHER ROLES & RESPONSIBILITIES:•Collaborate with external contract research organizations and data monitoring committees. •Survey clinical and statistical literature as appropriate

KEY CURRENT JOB RESPONSIBILITIES:•Collaborated with teams in designing oncology clinical studies and providing statistical support for clinical study reports.•Fostered cross-functional relationships with clinical, SAS programmers, medical writing and other functions as required.•Wrote Statistical Analysis Plans, Data Programming Specifications and contributed to clinical publications. •Contributed to discussions of analyses and proactively identified issues. SAS AND R EXPERIENCE IN DATA ANALYSIS:•Wrote code for data cleaning, manipulation, and exploration.•Applied statistical methodology for joint modeling of longitudinal and time to event data.•Applied Inverse Probability of Censoring Weighting (IPCW) and Rank Preserving Structural Failure Time (RPSFT) methods to correct for crossover. •Performed pharmacokinetics (PK) data analyses using SAS.•Performed power calculations using R, SAS, EAST, PASS, nQuery, and Addplan-Neo. OTHER ROLES & RESPONSIBILITIES:•Collaborated with external contract research organizations and data monitoring committees. •Kept up to date with guidelines from the FDA, EMEA, and other regulatory agencies. •Surveyed clinical and statistical literature as appropriate. •Presented technical details to lay groups as required.

KEY CURRENT JOB RESPONSIBILITIES:•Collaborated with teams in designing oncology clinical studies and providing statistical support for clinical study reports.•Fostered cross-functional relationships with clinical, SAS programmers, medical writing and other functions as required.•Wrote Statistical Analysis Plans, Data Programming Specifications. SAS AND R EXPERIENCE IN DATA ANALYSIS:•Wrote code for data cleaning, manipulation, and exploration.•Performed sensitivity analyses.

Wrote statistical sections of protocols for Phase I –II studies and statistical analysis plans for Phase I – II studies. Validated SAS programs to ensure proper function. Analyzed clinical data as appropriate. Surveyed statistical and clinical literature as appropriate. Reviewed CRFs and edit checks to ensure accuracy of data collection. Held leadership role as Project Biostatistician on clinical trials team.