Senior Biostatistician-Programmer - Pharmacovigilance Posted January 8, 2009 8  Years Experience Summit New Jersey

JOB DESCRIPTION: Responsibilities will include, but are not limited to, the following: 1. Provide statistical and programming support to global drug safety/Pharmacovigilance 2. Provide statistical input into the design of safety analysis plan including table shells - coordinate with study team statistician and lead safety MD 3. Analyze and report results of clinical trials, individual protocol, and aggregate analyses at indication and product level. 4. Program and generate tables, listings and graphs for interim analyses, preliminary reports and Final Safety/Statistical Reports for in-house use, DMC meetings, ad-hoc safety analyses, publications, regulatory submissions etc. 5. Provide tables, listings and graphs for final study reports and safety review as requested by the lead product development clinician and senior global drug safety leaders 6. Manage and maintain integration of global drug safety database and clinical trials database to provide integrated safety analysis as needed 7. Prepare SAS datasets and appropriate documentation for submissions as necessary 8. Manage outside CROs and consultants JOB REQUIREMENTS: Skills/Knowledge Required: Master's Degree/Ph.D. in statistics with focus on statistical methods appropriate for clinical trials & programming skill required to produce appropriate output. Demonstrated skills and experience in a statistical department including direct interaction with global drug safety personnel in the planning, analysis and reporting of safety data. Experience in ARISg safety system desirable. ? Detailed knowledge of statistical regulatory requirements and programming skills required for safety data analyses. Excellent SAS skills including report generation. ? In depth knowledge of all relevant SAS procedures and processes including interfaces with other systems (EXCEL, MS Word tables, Oracle Clinical). Basic understanding of descriptive epidemiology and epidemiological study designs (e.g. cross-sectional survey, case-control study, cohort study) and statistical approach used in it (e.g. logistic regression, proportional hazard model) Excellent interpersonal, communication, writing and organizational skills. Demonstrated ability to work in a team environment with medical personnel, epidemiologist, data managers, programmers and medical writers.