Apply📍 United States
🧭 Full-Time
💸 260000 - 280000 USD per year
🔍 Biopharmaceutical
🏢 Company: Praxis Precision Medicines, Inc.
- PhD in Biostatistics/Statistics or equivalent with a minimum of 10 years relevant experience, or MS in Biostatistics/Statistics with a minimum of 15 years relevant experience.
- Extensive experience with IND/NDA activities and regulatory interactions.
- Experience with interim analysis design and data monitoring committees.
- Broad knowledge of medical/biological terminology in relevant therapeutic areas.
- Excellent SAS programming skills, including SAS/BASE, SAS/STAT, SAS/GRAPH, and SAS Macros.
- Ability to perform simulations in programming languages such as SAS or R.
- Knowledge of GCP/ICH guidelines for clinical trials.
- Pharmaceutical experience with clinical trials and regulatory agency expectations.
- Effective communication skills in explaining methodology and analyses.
- Ability to manage multiple projects and adapt to changing priorities.
- Strong motivational skills to ensure productivity and operation.
- Provides statistical leadership and support for all clinical development activities.
- Applies innovative statistical approaches to study designs and analyses.
- Ensures accuracy of biostatistics deliverables in protocols and regulatory documents.
- Coordinates achievement of statistical deliverables across multiple clinical trials.
- Leads management of biostatistics resources and collaborates for timely deliverables.
- Monitors project progress and allocates resources effectively.
- Provides statistical leadership for marketing applications to regulatory agencies.
- Collaborates to develop standard processes for compliant data sets.
LeadershipGCPAnalytical SkillsCollaboration
Posted 2024-11-12
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