Remote opportunity at
pfm medical, inc.Principal Biostatistician
pfm medical, inc. is hiring a remote Principal Biostatistician for a full-time position providing statistical support across all clinical development phases. This role involves authoring statistical…
Career Tools
About This Role
pfm medical, inc. is hiring a remote Principal Biostatistician for a full-time position providing statistical support across all clinical development phases. This role involves authoring statistical analysis plans, handling complex study designs, generating SAS programs for datasets and reports, and leading statistical activities for clinical trials. The ideal candidate will act as a global consultant, interface directly with project teams, sponsors, and data monitoring committees, and oversee project budgets and…
Job Description
pfm medical, inc. is hiring a remote Principal Biostatistician for a full-time position providing statistical support across all clinical development phases. This role involves authoring statistical analysis plans, handling complex study designs, generating SAS programs for datasets and reports, and leading statistical activities for clinical trials. The ideal candidate will act as a global consultant, interface directly with project teams, sponsors, and data monitoring committees, and oversee project budgets and timelines.
Key duties include calculating sample sizes, creating randomization schedules, reviewing clinical study reports, and performing quality control for statistical programs. Professionals who possess extensive knowledge of regulatory guidelines and advanced statistical concepts will find this position well-suited to their background.
Responsibilities
- Write and review statistical sections of clinical study protocols and analysis plans
- Generate and verify randomization schedules and sample size calculations
- Develop SAS programs for tables, listings, figures, and analysis datasets
- Perform quality control checks for statistical SAS programs and study documents
- Provide unblinded statistical analysis and reports to Data Monitoring Committees
- Lead all statistical activities for assigned studies and oversee project budgets and monthly invoices
Requirements
- Experience with SAS programming
- Knowledge of industry standards including ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA regulations
- Broad understanding of advanced statistical concepts and techniques
Qualifications
- Master’s degree in Statistics, Biostatistics, or a related field with 10 or more years of experience, or a PhD in Statistics, Biostatistics, or a related field with 7 or more years of experience
- Prior experience working with oncology and rare disease indications
- Background in late-phase clinical trials and regulatory submissions
- Experience consulting with clients on study design and therapeutic area methodologies
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, the posting explicitly lists the remote status as remote.
What is the employment type?
The position is a full-time role.
What education and experience are required?
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 those fields with at least 7 years of experience.
What is the salary for this role?
The salary is not specified in the job posting.
Sample Interview Questions
AI-generated questions tailored to this specific role — a preview of the full practice set.