Job Description: - Performs biostatistical and programming activities for given clinical trials involving drugs, biologics and medical devices.&nbsp; - Be responsible for all statistical tasks with a high level of independence e.g. clinical trial design/planning, sample size estimations, analysis plan, defining safety, efficacy and exploratory endpoints, reporting activities including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase . - Ensure timeliness and adequate quality of all deliverables for the assigned trials and project tasks. Within the context of biological product development, defines, recommends, analyses and interprets the statistical part of projects in order to guarantee the statistical reliability of the conducted studies and dossiers and to allow the world-wide registration in compliance with the clinical development plan, good practices. - Ensure timeliness and adequate quality of all deliverables for the assigned trials and project tasks. Able to manage CRO deliverables. Follow processes and adhere to Health Authority requirements (SOP's, GCP and regulatory guidelines).Establish and maintain sound working relationships and effective communication within the Clinical Trial Team/Global Clinical Trial Teams Technical/Functional Skills : - Knowledge of applied parametric and non-parametric statistics, Mixed Model. Knowledge and experience in diabetes, immunology, oncology, MaBs, PKPD modeling, Generic Drug Development, innovative trial designs such as adaptive trials or Bayesian methods, biosimilars preferred. - Be knowledgeable in drug agencies (e.g. FDA) regulations and requirements governing the conduct of drug and medical device studies including, but not limited to, GCP and ICH requirements.&nbsp; - Knowledge and experience in pharmacokinetic studies required. WinNONLIN experience highly desirable. Experience with the following methodologies desirable: General Linear models - ANOVA, ANCOVA, t-test, F-test, etc (mixed models a plus); Non Parametric methods - Binomial test, Chi-Squared test, Wilcoxon tests; Logistic regression. Strong SAS/R programming Skills in R software specially PK PD Modelling.&nbsp; - Good knowledge of SAS Programming/R Programming. Good Knowledge of CDM, CDISC, SDTM &amp; ADaM programming. Past experience in diabetes, immunology, oncology, MaBs, PKPD modeling, Bayesian Statistics, innovative trial designs such as adaptive trials, group sequential and Bayesian Clinical Trials biosimilars preferred Preferred qualifications:&nbsp; - M. Sc in statistics with 4- 8 years in Pharmaceutical Industry experience. Good knowledge of SAS and R computer packages. Good project management skills.&nbsp; - Ability to work in multidisciplinary team (e.g., give guidance to non-statisticians, provide feedback,).Demonstrated oral and written communication in English including ability to explain difficult issues and situations clearly and ensures meaning is understood by non-statisticians within the organization

Bangalore

Senior Bio Statistician - Pharma    

Senior Bio Statistician - Pharma     ,Job Description for Senior Bio Statistician - Pharma     in BVR People Consulting in  Bangalore for (4-8) years of experience. Apply Now!

Job Description for Senior Bio Statistician - Pharma     in BVR People Consulting in  Bangalore for (4-8) years of experience. Apply Now!