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Senior Sales Associate - Full Time
The Aubuchon Company
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- $16 to $18 USD / hour
- Full-time
The Senior Sales Associate serves as a team lead within the store, supporting daily operations, customer service excellence, and team development. This role builds on foundational store…
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Provider Enrollment Certification Auditor/Documentation Specialist
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Remote, United States
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System Administrator (IT Operations) - Secret Clearance Required
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United States
The IT Operations team currently oversees the management and upkeep of the organization's IT infrastructure. Our expertise encompasses understanding of the organization's systems,…
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System Administrator - Secret Clearance Required
GD Information Technology, Inc.
United States
Information Technology (IT) Systems, Operations, System Administration, System Monitors, Technical SupportCertifications:
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Program Analyst Sr. Principal - FDA
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United States
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Duty Manager - Frontier Airlines Passenger Service
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Associate Veterinarian - Hoffman Animal Hospital
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Director, Healthcare Operations and Transformation
AArete
United States
Contribute to internal operations initiatives and thought leadership related to healthcare transformation, shared services optimization, workforce strategy, and digital enablement
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Kipling: Assistant Store Manager- Woodbury
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United States
- $24 to $36 USD / hour
…ensuring excellence in customer engagement, merchandising, operations, and community connection. In the Store Manager’s absence, you will assume full responsibility for the store. This role…
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Vans: Assistant Manager - Salt Lake City
VF
United States
- $20 to $30 USD / hour
…ensuring excellence in customer engagement, merchandising, operations, and community connection. In the Store Manager’s absence, you will assume full responsibility for the store. This role…
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Vans: Store Manager - Orange Park Mall
VF
United States
- $29.2 to $43.8 USD / hour
…excellence across all areas, directly impacting profitability, team development, and customer satisfaction. Ideal for a dynamic, people-focused leader who thrives in a fast-paced retail…
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Adjunct Welding Instructor- B2B
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Kitchen Manager
projects/helpful-passage-853/companies/30ad1728-df4c-4814-8980-df0542fd3503
Auburn Hills, MI
- $58,000 to $72,000 USD / year
…for a passionate, driven Kitchen Manager to join our culinary leadership team and help bring the energy, excitement, and flavor behind one of the most unique dining experiences around. If…
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Clinical Operations Manager
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Assistant Food Operations Manager
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Business Process Consultant II BPPI - Hybrid
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Part Sales Manager – Full Time
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…exceptional customer service. Managers and MITs play a key leadership role, expected to Live The Pledge and deliver WOW! Customer Service while executing store operations with excellence.…
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Part Sales Manager – Part Time
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Part Sales Manager – Full Time
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Assistant Store Manager
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Part Sales Manager – Part Time
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Part Sales Manager – Full Time
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Quality Control Team Lead - Night Shift
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Sr. Principal Systems Engineer II – Staff Systems Engineering Strategic Lead
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Rezolute

Director – Biostatistics

United States

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Job details

Pay: Rezolute (RZLT) currently anticipates the base salary for the Director of Biostatistics role could range from $240,000 to $310,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience.
Experience: 10+ years of biostatistical experience within the pharmaceutical, biotechnology, or CRO industry.
Posting language: English
Posted: Nov 3, 2026

Original job description

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of congenital and acquired forms of hyperinsulinism (HI). Rezolute’s mission is to bring hope and meaningful solutions to patients and families affected by rare diseases through scientific innovation, collaboration, and integrity.

Position Summary

We are seeking an accomplished Director, Biostatistics to provide strategic and operational leadership for the statistical function within a growing, late-stage biopharmaceutical company. The organization currently has two Phase III clinical programs advancing toward regulatory submissions and commercialization, creating an exciting opportunity for a highly experienced statistician to influence development strategy, regulatory interactions, and submission readiness.

The Director, Biostatistics will serve as the lead statistical expert across clinical development programs, partnering closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, Statistical Programming, and external vendors. This individual will ensure the design, analysis, interpretation, and reporting of clinical trial data meet the highest scientific and regulatory standards.

Experience in rare disease drug development and NDA/BLA submissions is strongly preferred.

Key Responsibilities

Statistical Leadership

Provide strategic statistical oversight for Phase III clinical development programs and future lifecycle management activities.
Lead the development of statistical strategies supporting clinical development plans, regulatory submissions, and post-hoc analyses.
Serve as the statistical lead for one or more products and represent Biostatistics on cross-functional program teams.
Advise senior management regarding statistical considerations, development risks, and mitigation strategies.

Clinical Trial Design & Analysis

Lead the design and statistical methodology for Phase II, Phase III, and long-term extension studies.
Author and review statistical sections of protocols, statistical analysis plans (SAPs), clinical study reports (CSRs), and submission documents.
Ensure high-quality analysis of efficacy, safety, patient-reported outcomes, and biomarker data.
Oversee endpoint selection, estimands, multiplicity strategies, interim analyses, and adaptive design considerations where appropriate.

Regulatory & Submission Support

Lead the statistical components of NDA/BLA/MAA submissions, including integrated efficacy and safety analyses, statistical documentation, responses to agency questions, and preparation for regulatory review and inspection.
Represent and defend statistical positions in interactions with global regulatory agencies, including FDA, EMA, MHRA, PMDA, and other health authorities.
Support preparation of briefing packages, meeting materials, and responses to regulatory questions.
Provide statistical leadership for NDA/BLA/MAA submission activities and inspection readiness.
Ensure compliance with ICH, FDA, EMA, and other relevant regulatory guidance.

Vendor & Functional Oversight

Manage and provide scientific and operational oversight of CROs, external biostatistics consultants, and statistical programming vendors.
Collaborate closely with Statistical Programming to ensure analysis datasets, TLFs, and submission deliverables are generated according to CDISC standards.
Review and approve key statistical deliverables to ensure quality, timelines, and regulatory compliance.

Cross-Functional Collaboration

Partner with Clinical Development physicians, Clinical Operations, Data Management, Safety, and Regulatory Affairs to support program objectives.
Present statistical findings to senior leadership, advisory boards, investigators, and external stakeholders.
Mentor and develop junior statisticians and contribute to the growth of the Biometrics organization.

Qualifications

Education

Ph.D. in Statistics, Biostatistics, Mathematics, or related quantitative discipline preferred.
Master's degree with significant industry experience will be considered.

Experience

10+ years of biostatistical experience within the pharmaceutical, biotechnology, or CRO industry.
Experience serving as lead statistician for late-stage clinical development programs.
Demonstrated involvement in Phase III clinical trials and regulatory submissions.
Experience supporting FDA and/or EMA interactions.
Rare disease development experience strongly preferred.
Prior experience in a small or emerging biotechnology environment is highly desirable.

Technical Skills

Strong comprehensive knowledge of clinical trial methodology, statistical theory, and regulatory requirements.
Expertise in ICH E9, estimands framework, adaptive trial designs, longitudinal data analysis, multiplicity methodologies, and missing data strategies.
Working knowledge of CDISC SDTM and ADaM standards.
Familiarity with SAS and R programming environments.
Experience reviewing outputs, analyses, and submission deliverables generated by statistical programming teams.

Leadership Competencies

Strategic thinker capable of balancing scientific rigor with business objectives.
Strong communication and influencing skills across technical and non-technical stakeholders.
Comfortable operating in a fast-paced, resource-conscious biotechnology environment.
Demonstrated ability to manage multiple priorities while meeting aggressive development timelines.
Collaborative, hands-on leader willing to work at both strategic and operational levels.

Preferred Experience

Rare disease, orphan drug, or ultra-rare disease development programs, analysis of continuous glucose monitoring in applicable therapeutic areas.
Experience supporting NDA, BLA, or MAA submissions.
Exposure to accelerated approval pathways or breakthrough designation programs.
Experience in a company transitioning from late-stage development to commercialization.
Prior leadership of biometrics vendors and global development programs.

Rezolute (RZLT) currently anticipates the base salary for the Director of Biostatistics role could range from $240,000 to $310,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience, and geographical location of the selected candidate.

Qualifying employees are eligible to participate in benefit programs such as:

Health Insurance (Medical / Dental / Vision)
Disability, Life & Long-Term Care Insurance
Holiday Pay
Tracking Free Vacation Program
401(k) Plan Match
Educational Assistance Benefit
Fitness Center Reimbursement

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.

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