Biostatistician Bio Stat Subject Matter Expert Florham Park, NJ Interested please call 301-760-7381 or mail resume to gayathrim@strategicits.com Position: Bi-Stats Lead Location: Florham Park NJ Duration: Long term Position Type: Permanent/Contract to Hire. Major Activities: 1. Be responsible for building a statistical analysis team to support Bio-State services for client's Pharmaceutical customers supporting solution and services development activities, as well as pre-sales and customer project delivery. Requirements Strong statistical and data analysis skills; strong knowledge of statistical and clinical trial methodology and services background. Solid hands-on experience as statistician in clinical development program. Good knowledge of drug development process. Experience in supporting NDA submissions and reporting. Strong ability in protocol development, analyze, EMR, Drug Safety and clinical trial reports/publications of Phase I-III clinical trials as well as OMAP, Adaptive and other emerge ring models. Very good oral and written communication skills. Knowledge of FDA/ICH guidelines. Good knowledge of SAS, S-Plus and R computer packages. Good project management skills. Desired Skills & Experience  Thorough understanding of e-submissions  Thorough understanding of eCTD  Thorough understanding of 21CFR parts 11, 54, 56, 312, and 314  Thorough understanding of ICH guidelines  Thorough understanding of regulatory guidances pertaining to specific indications but also to electronic submissions  Thorough understanding of regulatory data sciences  Thorough understanding of statistical issues in clinical trials  Thorough understanding of issues related to adaptive trials and OMAP  Acquaintance with Bayesian statistics  Extensive experience with SAS, R and other statically programming languages and tools required  Ability to work independently  Good analytical skills  Good project management skills  Professional attitude  Ability to work with others Communication:  Address technical issues effectively with written and verbal communication  Explain biostatistical and technical issues effectively to technical and non-technical staff  Requires a PhD or equivalent in Biostatistics or a related field and at least 8-10 years experience supporting the design of clinical trials and the analysis and reporting of clinical trials data in the pharmaceutical industry.  Experience supporting regulatory submissions for pharmaceutical product registration is required.