Senior Director - Biostatistics

March 27

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Ultragenyx

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Ultragenyx is a biopharmaceutical company dedicated to transforming the lives of individuals with rare and ultrarare genetic diseases. The company focuses on developing and delivering treatments for conditions where no current therapies exist, utilizing a variety of drug modalities tailored to each disease. Ultragenyx boasts a robust and diverse clinical pipeline, with therapies in development for genetic diseases such as Wilson Disease, osteogenesis imperfecta, and Angelman Syndrome. With a passionate team and a commitment to patient advocacy, Ultragenyx aims to lead the way in pioneering therapies that significantly impact rare disease communities.

rare disease • ultra-rare disease

501 - 1000 employees

Founded 2010

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Be a hero for our rare disease patients • Contribute to study level tasks from statistical perspective, including but not limiting to: input to 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 • Lead product level tasks including regulatory interactions and filings, ensuring statistical integrity; contribute strategically to Ultragenyx projects from statistical perspective. • Work collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting. • Translate statistical thinking into strategic input to advance the clinical program. • Independently conduct analyses suggested by the data; propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results. • Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements. • Lead developing department standards and research in advanced statistical methodologies. • Author/review regulatory documents or scientific publications • Oversee work by CRO and ensure quality deliverables.

🎯 Requirements

• PhD in Statistics or Biostatistics with a minimum of 13 years (minimum 15 years for master’s degree) of postgraduate experience in the clinical trials setting in the pharmaceutical industry • Experience leading NDA/BLA/MAA activities from statistical perspective, including direct regulatory interactions • 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; Prior experience in Rare Disease clinical development is preferred • Experienced in study level work including authoring SAP and TFL specification • Excellent statistical knowledge with the ability to apply this to scientific and clinical problems with experience in computational simulation, analysis of biomarkers, SAS programming, and other relevant software applications, statistical methodologies, theories, and analysis including adaptive designs and Bayesian analysis • Familiar with ICH guidelines, FDA/EMA/other regulatory authority guidance • Excellent communication and interpersonal skills • Detailed-oriented with organization, problem solving and prioritization skills • Familiar with SAS and R; knowledge of CDISC including SDTM, ADaM, and controlled terminologies.

🏖️ 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