
Lead Clinical Trials Biostatistician
3 days ago
A Senior Biostatistician is sought to lead the design and analysis of clinical trials for various clients on an ongoing contractual basis.
The successful candidate will have a strong background in biostatistics, with expertise in study design, statistical analysis, data visualization, and reporting.
This is a senior-level position that requires excellent leadership skills, as well as the ability to work independently and collaboratively as part of a team.
The ideal candidate will have a proven track record of delivering high-quality results, with experience working on multiple projects simultaneously.
Key Responsibilities:- Manage study design and statistical analysis for multiple simultaneous clinical trials, ensuring timely completion and high-quality results.
- Oversee all statistical aspects of projects, including protocol development, data management consulting, statistical analysis, data visualization, results write-up, and reporting.
- Author and/or review Statistical Analysis Plans (SAPs) centered around study protocols, ensuring alignment with regulatory guidelines.
- Perform initial meta-analyses to inform preliminary design and conduct interim analyses as required.
- 5+ years of experience leading projects in the pharma or biotech industry, with a strong track record of delivering high-quality results.
- Proficiency in at least one programming language, such as SAS or R.
- Experience in Phase 1 drug studies, medical device and diagnostic clinical trials, or algorithm validation studies.
- Advanced knowledge of biostatistical methodologies, including Bayesian techniques like Bayesian meta-analysis and Bayesian Adaptive designs.
- Familiarity with clinical research regulatory guidance and standards, such as ICH and EMA.
- Excellent communication skills, with experience working across different modalities.
- Optional: experience with modeling and simulation, and Bayesian statistical techniques.
- Mid-Senior level position.
- Contract employment type.
- Research, Analyst, and Information Technology job function.
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