Director, Biostatistics

Ultragenyx; United States; Remote; USD 212,000 - 263,000; Full time

Job summary

Join a forward-thinking company dedicated to transforming the landscape of rare disease medicine. As the Director of Biostatistics, you will play a crucial role in leading clinical study design and ensuring the integrity of statistical analyses. This position offers a unique opportunity to work remotely while contributing to impactful projects that prioritize patient needs. With a collaborative culture that fosters growth, you will have the chance to mentor junior staff and shape the future of innovative medicines. If you are passionate about making a difference and possess the necessary expertise, this role is perfect for you.

Qualifications

• 8+ years of experience in clinical trials with a focus on statistical integrity.
• Experience with NDA/BLA/MAA activities and regulatory interactions.

Responsibilities

• Lead product/indication tasks and ensure statistical integrity.
• Collaborate with cross-functional teams to meet deliverables.

Skills

Statistical Analysis

Clinical Trials

Leadership

Problem-Solving

Attention to Detail

Knowledge of ICH/FDA/EMA Guidelines

Education

PhD in Statistics or Biostatistics

Masters in Statistics or Biostatistics

Tools

SAS

R

Job description

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Why Join Us?

Be a hero for our rare disease patients

At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. Our vision is to lead the future of rare disease medicine by going where others won’t go—challenging the status quo and creating a new model that benefits more patients and caregivers. We do this by following the science, applying a rapid development approach, making innovative medicines at fair prices, and creating a collaborative ecosystem.

Our commitment extends to our culture, which is supportive and inclusive, fostering learning and growth for our employees. We aim to be an organization where employees are proud to work.

If you want to make a meaningful impact, do your best work, and grow professionally and personally, join our team.

Position Summary:

ultrafocused – Work together to uncover new possibilities.

The Director of Biostatistics leads programs, provides technical support on clinical study design, participates in data interpretation, regulatory submissions, and develops tracking systems for data quality. They help develop departmental standards, support project teams, and manage administrative functions related to project milestones.

Work Model:

Remote: Full-time from home, with occasional travel to offices or other locations.

Responsibilities:

• Lead product/indication tasks, including regulatory interactions and statistical integrity.
• Contribute to study design, sample size, protocol authoring, randomization, CRF review, and study meetings.
• Collaborate with biometrics and cross-functional teams to meet deliverables.
• Ensure statistical integrity and provide scientific methodology input.
• Conduct analyses, propose new methods, and contribute to research and standards.
• Author/review regulatory documents and mentor junior staff.

Requirements:

• PhD in Statistics or Biostatistics with 8+ years (Masters: 11+ years) of experience in clinical trials.
• Experience with NDA/BLA/MAA activities and regulatory interactions.
• Leadership experience in statistical strategy, managing multiple projects, authoring SAP and TFL.
• Knowledge of ICH, FDA, EMA guidelines.
• Strong mathematical/statistical skills, experience with longitudinal data preferred.
• Attention to detail, organization, problem-solving, proficiency in SAS and R, knowledge of CDISC standards.

Salary range: $212,500—$262,500 USD, with bonuses and benefits.