Senior Biostatistics Expert
5 days ago
We are seeking a highly skilled Senior Biostatistician to join our team at the Precision Medicine Group. As a key member of our clinical development team, you will be responsible for providing statistical support and expertise in the design, execution, and interpretation of clinical trials.
About the Role:This is a challenging and rewarding opportunity for an experienced biostatistician who wants to make a meaningful contribution to the field of precision medicine. You will work closely with cross-functional teams, including clinicians, data managers, and regulatory experts, to ensure that studies are conducted efficiently and effectively.
Responsibilities:- Design and implement statistical methods for clinical trials, including randomization schedules, sample size calculations, and analysis plans;
- Develop and review statistical protocols and reports, ensuring compliance with industry standards and regulatory requirements;
- Collaborate with study sponsors, project managers, and external vendors to ensure timely and high-quality delivery of statistical results;
- Lead statistical activities on studies, including budget planning, resource allocation, and oversight of programming and quality control;
- Communicate complex statistical concepts and results to non-technical stakeholders, including study sponsors, project managers, and Data Monitoring Committees (DMCs);
To be successful in this role, you will need:
- A Master's degree or equivalent in Statistics, Biostatistics, or a related field, with 10+ years of experience; or a PhD degree in Statistics, Biostatistics, or a related field, with 7+ years of experience;
- Advanced knowledge of SAS programming and proficiency in statistical software packages;
- Experience working with industry standards, such as ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines;
- Broad knowledge and superior understanding of advanced statistical concepts and techniques, including regression analysis, survival analysis, and Bayesian modeling;
- Experience working in oncology and rare diseases, as well as late-phase and submission projects;
- Superior communication skills and ability to work collaboratively in a fast-paced environment.
In addition to a competitive salary, we offer a comprehensive benefits package, including medical, dental, and vision coverage, as well as a generous retirement plan. You will also have opportunities for professional growth and development, including training, mentorship, and conference attendance.
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