Darshak Patel

Senior Biostatistician @精鼎医药

Developing statistical analysis plans and TLF shells; overseeing, leading, and contributing statistical analysis, SAS programming, preparation for aCRF, SDTM, cSDRG, ADaM, ADRG, Define.xml, TLF outputs, etc. for phase clinical trials in Rare Disease area. Collaborating with other function areas on designing, reviewing, and commenting CRFs, data monitoring plan, risk management plan, protocol deviation, etc. Daily management work in biostatistics /programming for weekly project and sponsor meetings, bid defense meeting, study progress check, timeline initiation, budget projection, resource review, forecast, and request, discussing and solving problems, etc. Coordinate and lead a project team to successful completion of a project within timelines and budget Interact with clients as key contact with regard to statistical and contractual issues Perform QC of derived datasets, tables, figures and data listings produced by other members of the department Understand and apply advanced statistical methods Lead production and quality control of randomizations, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review Travel to, attend and actively contribute to all kind of client meetings as appropriate (eg discussing analysis concepts, presenting, discussing and interpreting study results) Support of Business Development, eg by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings for potential studies, programs of work and FSPs