Perform and plan: (i) the programming, testing, and documentation of programs for use in creating statistical tables, figures and listing summaries, (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients. May perform and plan the programming of database quality control checks. Program the integration of databases from multiple studies or sources. Develop programming documentation including plans and specifications, as appropriate. Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to teams and department. Perform and plan the development, implementation and validation of new process technologies, macros and applications. Fulfill project responsibilities at the level of statistical team lead for single studies, under supervision. Understand the Scope of Work, estimate the work completed, and manage Out of Scope for single studies. May manage budget and resource requirements and provide revenue and resource forecasts for single studies. May be required to understand budget and quote assumptions. Provide training and guidance to lower level and new staff.
Skills and Abilities: Minimum 3+ years of experience on ADaM and TFL (SDTM experience is optional), PHD degree 1 years working experience. Position is open for Oncology TA, so candidate should have Oncology experience working on ADTTE, ADRS, ADTU, ADTR datasets and KM Plots, Forest Plots, Swimmer lane plot, waterfall plot etc. Good understanding of RECIST Guidelines in Oncology is a must. R experience is nice to have – Should be using R to create QC of TFLs, Strong R programming applications in clinical trials on day to day basis. English can be working language.
