• Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies. 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.
• 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.