6-month remote contract-to-hire
- PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with 3 years of relevant work experience OR a Masters degree in Statistics or Biostatistics or a related health science field, and 5 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
- 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.
- Learning agility and ‘scalability’ to take on increasing responsibility as Intercept grows
- Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
- Ability to have fun and thrive in a growing, diverse and inclusive work environment
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