Director, Biostatistics

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

Job summary

An innovative biopharmaceutical company is seeking a Director of Biostatistics to lead statistical efforts in clinical trials. This role involves providing technical leadership, ensuring statistical integrity, and contributing to regulatory submissions. The ideal candidate will have extensive experience in the pharmaceutical industry, a PhD in Statistics or Biostatistics, and a passion for advancing rare disease medicine. Join a collaborative team dedicated to impactful patient care and professional growth in a supportive remote work environment.

Benefits

Generous vacation time

Volunteer days

Long-term incentive plans

Employee stock purchase plans

Wellbeing benefits

Fitness reimbursement

Tuition sponsoring

Professional development plans

Qualifications

• 8+ years of experience in clinical trials within the pharmaceutical industry.
• Expertise in NDA/BLA/MAA activities and regulatory interactions.
• Strong understanding of ICH guidelines and FDA/EMA regulations.

Responsibilities

• Lead statistical tasks for regulatory submissions and ensure statistical integrity.
• Contribute to study design, sample size determination, and protocol authoring.
• Mentor junior team members and ensure compliance with statistical methodologies.

Skills

Statistical Analysis

Biostatistics

Clinical Trials

Regulatory Submissions

SAS

R

Data Quality Assurance

Statistical Methodologies

Education

PhD in Statistics or Biostatistics

Masters in Statistics or Biostatistics

Tools

SAS

R

CDISC

Job description

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.To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.

Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work.Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally andpersonally, come join our team.

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Director of Biostatistics acts as program statistical lead; provides technical leadership and biostatistical support on the design and conduct of clinical studies; participates in the evaluation, interpretation, and reporting of study results, in regulatory submissions to the FDA and other regulatory agencies; performs statistical analyses and develops tracking systems for data quality assurance.

The Director of Biostatistics contributes to identifying, developing and implementing departmental standards, applications, processes and training. Provides timely support to the project teams on all statistical matters according to the project strategies and is responsible for addressing all administrative functions required for project management and milestones, identifying and communicating changes in project requirements that may affect key deliverables at the project level.

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Lead in product / indication level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from statistics perspective.
• Contribute to study level tasks from statistics perspective, including: study design and sample size determination; Author/review statistics section in the protocol, SAP and DMC charter; Create/review study randomization files; Develop TFL shell and specification Review CRFs and other study documentations; Active participation in study related meetings.
• Works collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting.
• Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements.
• Independently conduct analyses suggested by the data; Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results.
• Contribute to developing standards and research in advanced statistical methodologies.
• Author/review regulatory documents or scientific publications.
• Mentor junior team members.

Requirements:

• PhD in Statistics or Biostatistics with a minimum of 8 years (min 11 years for Masters) of post-graduate experience in the clinical trials setting in the pharmaceutical industry.
• Experienced in NDA / BLA / MAA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction.
• Experienced as product lead statistician and contributing to strategy discussion in cross functional settings; Experienced in managing multiple products and studies and being able to prioritize.
• Experienced in study level work including authoring SAP and TFL specification.
• Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance.
• Solid understanding of mathematical and statistical principles; Experience in statistical methods analyzing longitudinal data is preferred.
• Detailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according to company timeline.
• Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies. #LI-CS1#LI-Remote

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range

$212,500—$262,500 USD

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

· Generous vacation time and public holidays observed by the company

· Volunteer days

· Long term incentive and Employee stock purchase plans or equivalent offerings

· Employee wellbeing benefits

· Fitness reimbursement

· Tuition sponsoring

· Professional development plans

* Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [e-mail].

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Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to:[e-mail].