This job is currently Archived,
Posted on : 26 February 2017
ESSENTIAL FUNCTIONS: " Provide timely and scientifically sound statistical expertise to clinical development projects. " Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies. " Work closely with data management, clinical operations, programming, and other biostatisticians to develop and validate study-specific data capture systems " Develop statistical analysis plans (SAPs) to meet regulatory standards, coordinate and perform data analysis and validation as necessary, and provide data interpretation. " Produces table, figure, and listing templates for reporting of study results and data. " Assists in the development of study protocols, provides sample size estimates and power calculations for complex study designs, and oversees generation of randomization schedule for complex randomization schemes. " Reviews study protocols, CRFs, Data Validation Specifications (DVS), and other study-related documents in order to ensure correctness of statistical representation of data and results, and collection of required data. " Writes specifications for datasets, tables, figures, listings, and consistency checks for both efficacy and safety analyses; performs validation of key statistical results. " Analyzes clinical trial data producing accurate results representing the outcome of the trial. Validates statistical output. " Performs statistical analysis for publication. " Provides input in preparation of study reports, with particular emphasis on the statistical methods section, and works closely with Medical Writing in study report preparation. " Collaborate with clinical scientists, thought leaders, and medical writers, both internally and externally, in the publication of study data. " Stay current with new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc. " Other duties as assigned. QUALIFICATIONS: " The Senior Biostatistician has a PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with one year of relevant work experience OR a Masters degree in Statistics or Biostatistics or a related health science field, and 2-3 years of biostatistical experience in the clinical trials or health research environment. " Comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics " Familiarity with pharamcokinetic/pharmacodynamic data, a plus " Experience supporting publication of analysis results (e.g. abstracts, posters, manuscripts) a plus " Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines. " Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies a plus " eCTD BLA/NDA experience as well as past interaction with FDA and/or interaction with EMA/CPMP and preparation of MAA a plus REQUIRED KNOWLEDGE AND ABILITIES: " Knowledge of CDISC requirements for SDTM and ADaM " Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS. " Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required. " Exceptional interpersonal skills and problem solving capabilities. " Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure, and in a team environment to meet established deadlines. " Requires understanding of the company s products, the competition, and the pharmaceutical industry in general " Maintains current awareness of new drug developments in the business.
San Diego CA United States
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