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Sr. Biostatistician San Diego United States,  

Intercept (company)


Posted on : 26 February 2017

Project Description

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 data-sets, 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. 

Locations

San Diego CA United States

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