Job Description
Job Title: Statistics Manager
Location: Remote (Must reside in the Massachusetts region)
Type: Full Time
Up to 100% remote work available from anywhere in the U.S
Our client is seeking a Manager, Statistics to provide advanced statistical leadership in the design, analysis, and interpretation of clinical trials. In this role, you will support quantitative decision‑making across development programs, guide statistical strategy, and ensure high‑quality deliverables for regulatory submissions.
- What You’ll Do
- Provide statistical expertise for clinical trial design, data analysis, and interpretation to support compound‑level decisions.
- Serve as the statistical representative on global, cross‑functional development teams.
- Develop and review key statistical documents, including study protocols, statistical analysis plans, clinical study reports, and submission materials.
- Ensure statistical deliverables meet quality standards, align with regulatory expectations, and are delivered on schedule.
- Lead and oversee analysis and reporting activities, including work performed by statisticians and programmers.
- Apply and promote advanced statistical methods, innovative trial designs, and analytical techniques.
- Utilize both internal and external resources to ensure efficient, cost‑effective project execution.
- Stay current with industry trends and contribute new ideas to optimize study designs and statistical methodologies.
- What You Bring
- Ph.D. in Mathematics, Biostatistics, Statistics, or a related quantitative field.
- Experience with innovative study designs, complex analytical methods, and statistical simulations to support clinical research.
- Hands‑on expertise with statistical programming tools such as SAS, R, MATLAB, or similar platforms.
- Comprehensive knowledge of FDA and ICH guidelines, clinical trial standards, and regulatory submission requirements.
- Proven experience overseeing statistical activities, including SDTM/ADaM standards and development of tables, figures, and listings (TFLs).
- Benefits
- Eligibility for short‑term and long‑term incentive programs
- Medical, dental, and vision insurance
- 401(k) with employer match
- Short‑term and long‑term disability coverage
- Basic life insurance
- Tuition reimbursement
- Paid volunteer time
- Company holidays
- Wellness and well‑being programs
- Up to 80 hours of sick time annually
- Vacation accrual up to 120 hours for new hires
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