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Precision Medicine GroupPrincipal Biostatistician
Precision Medicine Group is hiring an on-site Principal Biostatistician to deliver statistical leadership across clinical development stages. This position involves authoring statistical analysis plans, executing complex…
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About This Role
Precision Medicine Group is hiring an on-site Principal Biostatistician to deliver statistical leadership across clinical development stages. This position involves authoring statistical analysis plans, executing complex study designs, managing project budgets, and serving as an unblinded biostatistician for Data Monitoring Committees. The professional will act as a global consultant, collaborate with external sponsors and vendors, and oversee programming tasks utilizing SAS. This role suits an experienced statistical professional equipped to…
Job Description
Precision Medicine Group is hiring an on-site Principal Biostatistician to deliver statistical leadership across clinical development stages. This position involves authoring statistical analysis plans, executing complex study designs, managing project budgets, and serving as an unblinded biostatistician for Data Monitoring Committees. The professional will act as a global consultant, collaborate with external sponsors and vendors, and oversee programming tasks utilizing SAS. This role suits an experienced statistical professional equipped to handle regulatory submissions, mentor staff, and contribute to departmental procedures.
Responsibilities
- Write and review statistical sections for clinical study protocols and reports
- Develop statistical analysis plans incorporating complex study designs and late phase methodologies
- Generate randomization schedules and compute sample size determinations
- Create datasets, tables, figures, and listings via SAS programming
- Perform quality control for statistical SAS programs, presentations, and reports
- Deliver unblinded statistical reports to Data Monitoring Committees
- Lead study statistical operations within established timeframes and monitor project financial health
- Communicate directly with sponsors, project teams, and external vendors
Requirements
- Experience utilizing SAS software
- Familiarity with industry regulations including FDA guidelines, ICH standards, CDISC data structures, and 21 CFR Part 11
- Proficiency in advanced statistical techniques and clinical trial principles
- Legal authorization to work in the employment country without requiring employer sponsorship
Qualifications
- Master's degree in Statistics, Biostatistics, or a related field coupled with ten or more years of relevant experience
- Doctoral degree in Statistics, Biostatistics, or a related field coupled with seven or more years of relevant experience
- Prior background working with oncology and rare disease indications
- Experience handling late phase studies and regulatory submissions
- Background in client consulting regarding study design and specialized statistical methods
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the work location arrangement for this role?
The posting specifies that this is an on-site position.
What education and experience are required to apply?
Candidates must hold either a Master's degree in Statistics, Biostatistics, or a related field with at least 10 years of experience, or a PhD in the same fields with a minimum of 7 years of experience.
Is salary information provided in the job posting?
No, the salary is not stated in the source posting.
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