- 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.
- Develops templates for ISS and ISE statistical tables for regulatory submission in conjunction with clinical, and provides specs and supervision for production of ISS and ISE tables.
- Reviews ISS and ISE reports towards regulatory submission.
- 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.
- Responds to questions from the FDA and other regulatory authorities on statistical issues. Attend regulatory meetings to support and defend clinical programs.
- 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.
- Train and mentor new statisticians.
- Other duties as assigned
- PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with four (4) years of relevant work experience OR a Masters degree in Statistics or Biostatistics or a related health science field, and 5-7 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.
- eCTD BLA/NDA experience as well as past interaction with FDA and/or interaction with EMA/CPMP and preparation of MAA
Required Knowledge and Abilities
- Knowledge of CDISC requirements for SDTM and ADaM
- Exceptional interpersonal skills and problem solving capabilities.
- 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.
- 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