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Company

Original Job Post

Ultragenyx · 1 week ago

Director, Biostatistics

United States

Full-time

Remote

Director

$201K/yr - $249K/yr

8+ years exp

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BiotechnologyHealth Care

H1B Sponsorship

Comp. & Benefits

Hiring Manager

Chastity Summers

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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

Qualification

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NDA/BLA/MAA ActivitiesProduct LeadStudy Level WorkSAPTFL SpecificationICH GuidelineFDA/EMAMathematical PrinciplesStatistical PrinciplesLongitudinal Data AnalysisSASRCDISCSDTMADaMControlled TerminologiesProblem SolvingOrganizationPrioritizationDetail OrientedStatistical Analysis

Required

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

Preferred

Experience in statistical methods analyzing longitudinal data is preferred

Benefits

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

Company

Ultragenyx

Glassdoor

3.6

Leading with purpose. Every day.

Founded in 2010

Novato, California, USA

1,001-5,000 employees

http://www.ultragenyx.com

H1B Sponsorship

Ultragenyx has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (10)

2022 (15)

2021 (15)

2020 (8)