Akshay Kadam — Associate Consultant

Experienced Biostatistician with expertise in statistical programming, data analysis, and pharmacokinetic evaluations for clinical trials. Proficient in generating blinded/unblinded randomization schedules, performing sample size justifications, and providing statistical inputs for clinical study protocols. Skilled in conducting statistical analyses, calculating PK parameters, and generating TLFs as per protocol requirements using SAS. Proven track record in preparing statistical reports, contributing to Clinical Study Reports, and performing thorough QC of statistical outputs. Experienced in handling sponsor and regulatory queries, and successfully managing audits from WHO, USFDA, EMA, and CDSCO. Adept at interpreting clinical data, developing SAS codes tailored to study designs, and ensuring compliance with regulatory standards in early-phase studies. Technical Skills: SAS, R, Phoenix WinNonlin

Stackforce AI infers this person is a Biostatistician specializing in clinical trials and data analysis within the healthcare industry.

Location: Pune, Maharashtra, India

Experience: 4 yrs 7 mos