Top 177 Sr statistician Jobs

Senior Director Biostatistics - REMOTE
Penfield Search Partners —Remote
- Remote
- Doctor of Philosophy
- Neurology
- Mentoring
Quick Apply
Biostatistics Sr Mgr
Amgen —Remote
- $154,104.15 - $208,493.85 a year
- Remote
- Doctoral degree
- Master's degree
- High school diploma or GED
- Disability insurance
- Health insurance
Senior Survey Research Statistician
Gallup —Washington, DC
- $175,000 - $190,000 a year
- Hybrid work
- Office
- Doctor of Philosophy
- Mentoring
- Health insurance
- Dental insurance
Senior Director, Global Clinical Development - Late HOCT
BMS —Princeton, NJ
- $313,200 - $425,060 a year
- Email
- Hybrid work
- Medicine
- Doctor of Philosophy
- Travel
- Paid holidays
- Disability insurance
Senior Manager
BMS —Princeton, NJ
- $164,110 - $198,862 a year
- Email
- Hybrid work
- Computer Science
- Master's degree
- SQL
- Paid holidays
- Disability insurance
Senior Principal Statistician
Jazz Pharmaceuticals —Philadelphia, PA
- $156,000 - $234,000 a year
- Remote
- Analysis skills
- Doctor of Philosophy
- Senior level
- Health insurance
- Dental insurance
Senior Principal Statistician
Jazz Pharmaceuticals —Palo Alto, CA
- $156,000 - $234,000 a year
- Remote
- Analysis skills
- Doctor of Philosophy
- Senior level
- Health insurance
- Dental insurance
Senior Statistician
Katalyst Healthcares & Life Sciences —Edison, NJ
- Contract
- 6 years
- Doctor of Philosophy
- Organizational skills
Quick Apply
Senior Engineer - Statistician
Planned Systems International, Inc. —Remote
- Full-time
- Remote
- Microsoft Excel
- Microsoft Outlook
- SQL
- AD&D insurance
- Disability insurance
Senior Engineer/Scientist - Statistician
Planned Systems International, Inc. —Remote
- Full-time
- Remote
- Microsoft Excel
- Microsoft Outlook
- SQL
- AD&D insurance
- Disability insurance
Sr. Principal Biostatistician
Biogen —Remote
- $134,000 - $179,000 a year
- Full-time
- 3 years
- Analysis skills
- Continuous improvement
- Paid parental leave
- Employee stock purchase plan
Senior Director, Biostatistics
Perspective Therapeutics —Remote
- $240,000 - $300,000 a year
- Full-time
- Master's degree
- Databases
- Analysis skills
Quick Apply
Sr. Computational Statistician (R2 – R3)
Eli Lilly —Indianapolis, IN
- $46,842 - $117,289 a year
- Full-time
- Master's degree
- Databases
- In-person
- Health insurance
- Dental insurance
Statistician-Senior – 20163300
UT Health Science Center San Antonio —San Antonio, TX
- Online Application
- Background check
- 5 years
- Bachelor's degree
Quick Apply
Senior Statistician (RWD/RWE)
BeiGene —Remote
- $121,400 - $161,400 a year
- Full-time
- Master's degree
- Doctor of Philosophy
- Travel
- Health savings account
- Employee stock purchase plan
Senior Statistician
Costello Medical —New York, NY
- $100,000 a year
- Online Application
- Hybrid work
- Management
- Customer service
- English
- Health insurance
- Dental insurance
Quick Apply
Sr Biostatistician
Medline Industries —Illinois
- $101,000 - $152,000 a year
- Full-time
- Mid-level
- Master's degree
- Math
- Health insurance
- 401(k)
Senior Statistician
Genentech —San Francisco, CA
- $136,900 - $254,200 a year
- Online Application
- 3 years
- Analysis skills
- Doctor of Philosophy
Sr Statistician - Site Location Analyst
HEB —San Antonio, TX
- Extended hours
- Office
- Microsoft Office
- 3 years
Senior Statistician
NextGen Federal Systems —Scott AFB, IL
- Full-time
- Office
- Master's degree
- Analysis skills
Quick Apply

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Senior Director Biostatistics - REMOTE

Penfield Search Partners
Remote

Quick Apply

Job Details

Qualifications

FDA submissions
Statistics
Statistics
Biostatistics-based research
Team leadership
Drug regulation
ICH guidelines
Doctor of Philosophy
Pharmaceutical company experience
CDISC standards
Managing clinical research teams
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Clinical trial support in drug product development
Legal compliance
Senior leadership

Full Job Description

Our client is a clinical-stage biotechnology company focused on developing innovative therapies for patients with serious central nervous system (CNS) disorders. Their mission is to advance transformative treatments that address significant unmet medical needs and improve the lives of patients and their families. As they continue to progress our clinical programs, they are seeking a strategic and hands-on Senior Director, Biostatistics to join their growing team.

Position Summary
The Senior Director, Biostatistics will provide statistical leadership across the clinical development programs and play a critical role in advancing our assets through key development and regulatory milestones. Reporting to senior clinical development leadership, this individual will serve as the lead statistician for clinical studies, providing expertise in trial design, statistical methodology, analysis planning, data interpretation, and regulatory submissions.

This role is ideal for an experienced biostatistics leader who thrives in a fast-paced biotech environment, enjoys working cross-functionally, and is comfortable rolling up their sleeves to support both strategic and operational activities. The successful candidate will have extensive experience supporting regulatory submissions and managing external CRO partners while contributing to overall development strategy.

Key Responsibilities

Serve as the statistical lead across clinical development programs, providing strategic and technical leadership from study design through regulatory submission.
Lead the development and review of study protocols, statistical analysis plans (SAPs), randomization specifications, TLF shells, clinical study reports, and regulatory submission documents.
Provide statistical expertise for Phase 1, Phase 2, and Phase 3 clinical studies.
Collaborate closely with Clinical Development, Clinical Operations, Data Management, Statistical Programming, Medical Writing, Regulatory Affairs, and Pharmacovigilance teams.
Oversee and manage CROs and external statistical programming vendors to ensure high-quality deliverables, timeline adherence, and regulatory compliance.
Support interactions with regulatory agencies, including preparation for FDA meetings and responses to health authority questions.
Guide endpoint selection, sample size calculations, estimand strategies, interim analyses, and overall statistical methodology.
Review and interpret clinical study results and communicate findings to cross-functional teams and executive leadership.
Ensure compliance with CDISC standards, ICH guidelines, and regulatory expectations.
Contribute to clinical development plans, target product profiles, and overall program strategy.
Support due diligence activities, investor communications, and corporate presentations as needed.
Help establish and refine biostatistical processes and standards appropriate for a growing biotechnology company.

Qualifications
Required

PhD in Statistics or Biostatistics.
Minimum of 10 years of biostatistics experience within the pharmaceutical, biotechnology, or CRO industry.
Significant experience serving as lead statistician for clinical development programs.
Demonstrated success supporting NDA, BLA, and/or other major regulatory submissions.
Strong understanding of FDA, EMA, and ICH regulatory requirements.
Experience overseeing CROs and external statistical programming resources.
Knowledge of CDISC standards, including SDTM and ADaM.
Experience supporting Phase 2 and Phase 3 clinical trials.
Strong communication, leadership, and influencing skills.
Ability to work effectively in a lean, fast-moving biotech environment where flexibility and hands-on involvement are essential.

Preferred

Prior experience in CNS, psychiatry, neurology, neurodegenerative diseases, or other neuroscience therapeutic areas.
Experience supporting FDA meetings and regulatory interactions.
Familiarity with adaptive designs, Bayesian methodologies, or innovative clinical trial approaches.
Previous people leadership and mentoring experience.
Experience working in small or emerging biotechnology companies.

Quick Apply

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