Biostatistician II
Company: Disability Solutions
Location: Boston
Posted on: October 26, 2024
Job Description:
About the Job
The Biostatistician II is responsible for providing statistical
expertise and managing the activities for personalized medicine
companion diagnostic device analytical and clinical studies. This
position ensures valid and efficient study designs that allow
clearly interpretable results and timely delivery of data analyses,
study reports and regulatory documents with high quality. The
incumbent builds and maintains strong collaboration with other
teams across the organization to develop study plans, study
protocol as well as perform statistical analysis, write study
reports, provide responses to statistical issues arising in
regulatory or external partners, represent FMI at regulatory agency
(FDA, PMDA) meetings, and/or work with internal and external
partners (e.g. Biopharma) for the development and approval of FMI's
diagnostic assays.
Key Responsibilities
- Lead the design and data analysis of analytical and clinical
validation studies on novel next generation sequencing-based
companion diagnostic devices for oncology.
- Represent the team within broad cross-functional projects and
oversee multiple project teams.
- Mentor junior members on design and project
deliverables.
- Provide key contributions to the analytical and clinical
studies in the program, including but not limited to protocol
development, statistical analysis plans, and data
reporting.
- Contribute to the planning and delivery of key analytical or
clinical components of regulatory submissions, including but not
limited to Q-subs, PMA, and sPMA.
- Represent Biostatistics in internal submission /key regulatory
meetings.
- Develop innovative and creative statistical and technical
solutions to complex problems.
- Maintain statistics quality standards throughout the study
process and statistical accuracy in all documents pertaining to the
study.
- Ensure statistical work is completed in accordance with
established timeframes.
- Collaborate with laboratory scientists, technologists and the
Regulatory team on study design, planning, data preparation,
programming, analysis and presentation of results.
- Draft study protocols and issue final reports on these
studies.
- Maintain availability to the wider FMI business for statistical
interpretation and analysis.
- Other duties as assigned.
Qualifications
Basic Qualifications
- Master's Degree in Statistics (or Biostatistics)
- 2+ years of experience as a statistician in academia or in the
biopharmaceutical or diagnostics industry, academia, or FDA or PhD
in Statistics (or Biostatistics)
- Proficiency in statistical programming language R or SAS
Preferred Qualifications
- Doctor of Philosophy in Biostatistics or Statistics
- 1+ year(s) of experience as a statistician in academia or in
the biopharmaceutical or diagnostics industry
- Experience in time-to-event data analysis, cluster/longitudinal
data analysis, random effect and measurement error models
- Experience in experimental study design
- Extensive scientific understanding of cancer genetics and
genomics
- Knowledge and experience with Next-Generation Sequencing
(NGS)
- Experience leading or managing a team of
Biostatisticians
- Demonstrated ability to meet project deadlines
- Demonstrated record of successful independent work and
contributions to team projects
- Demonstrated leadership skills including proactive strategy
setting, priority evaluations, conflict resolution, and effective
partnerships
- Ability to work well under pressure while maintaining a
professional demeanor
- Strong programming skills, technical proficiency, and
creativity
- Excellent communication, presentations and writing skills, and
the ability to explain complex technical details in clear
language
- High level of detail orientation with a focus on
quality
- Understanding of HIPAA and importance of privacy of patient
data
- Commitment to FMI values: patients, innovation, collaboration,
and passion.
#LI-Hybrid
Keywords: Disability Solutions, Worcester , Biostatistician II, Other , Boston, Massachusetts
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