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AskBio Inc.
AskBio Inc.
501 – 1 000 Xodimlar
Ishlab chiqarishKonsaltingSog‘liqni saqlash
AskBio Inc. kam uchraydigan va genetik kasalliklar uchun gen terapiyalarini ishlab chiqayotgan klinik bosqichdagi sog‘liqni saqlash kompaniyasidir. Uning faoliyati adeno-assotsiatsiyalangan virus (AAV) texnologiyasiga, jumladan xususiy kapsidlar, promotorlar hamda Pro10™ va neDNA™ kabi ishlab chiqarish platformalariga qaratilgan. Bayer AG kompaniyasiga to‘liq tegishli bo‘lsa-da, mustaqil faoliyat yuritadigan sho‘ba korxona sifatida AskBio davolash usullarini kashfiyot bosqichidan insonlar ishtirokidagi tadqiqotlargacha ilgari surish uchun tadqiqot, klinik ishlab chiqish, ishlab chiqarish va hamkorlik tajribalarini birlashtiradi. Kompaniya akademik va sanoat hamkorlari bilan ham ishlaydi hamda kech boshlanuvchi Pompe kasalligiga mo‘ljallangan AB-1009 kabi klinik dasturlarni o‘z ichiga olgan, bemorlarga yo‘naltirilgan tadqiqotlarni qo‘llab-quvvatlaydi.
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Kompaniyadagi ish o‘rinlari

Senior Director, Biostatistics and Clinical Operations - Durham Hybrid

Lead biostatistical strategy for AskBio’s gene therapy clinical development programs, including trial design and regulatory planning. Manage statisticians and collaborate with cross-functional teams in a hybrid U.S. role.

USAmerika Qo‘shma ShtatlariNCShimoliy KarolinaOHOgayoPAPensilvaniyaGibridTo‘liq stavkaSeniorTalab Qilinadigan Til: inglizchaKlinik operatsiyalar

Tavsif

  • Lead technical strategy and operational oversight for non-clinical, CMC, and clinical development programs, studies, and trials, from design through reporting
  • Review clinical trial designs and reports prepared by other biostatisticians
  • Direct statisticians, programmers, and data managers to deliver accurate work on schedule
  • Counsel senior leaders and functional heads on biostatistical strategy and issues affecting the business
  • Oversee CRO biostatistics activities, scopes of work, and relationships with external statistical consultants
  • Allocate resources, establish priorities, and maintain compliance with applicable standards
  • Partner on protocol development, including study design, endpoint definition, and power and sample size calculations
  • Direct statistical analysis plans, data analyses, and clinical study report content
  • Contribute to Data Monitoring Committee charters and meeting preparation
  • Represent AskBio and the Biostatistics function in discussions with the FDA, EMA, and other health authorities
  • Contribute to regulatory submissions and agency interactions, including IND and BLA filings and potential partnering activities
  • Provide statistical expertise for clinical development plans, protocols, investigator brochures, regulatory submissions and responses, publications, and presentations
  • Create and explain solutions to statistical and data analysis challenges across clinical, regulatory, and commercial functions
  • Help maintain departmental SOPs, standardization initiatives, and statistical training programs
  • Stay current with statistical methods, drug development practices, and regulatory requirements
  • Evaluate external study designs and clinical trial data as part of due diligence activities
  • Contribute to business development efforts at conferences and industry events
  • Support scientific and medical meetings, including investigator meetings, advisory boards, DMCs, SABs, and engagements with key opinion leaders
  • Represent AskBio through presentations at industry conferences
  • Contribute to vendor assessment, selection, and oversight

Talablar

  • Ph.D. or M.S. in Statistics or a related discipline
  • At least 10 years of pharmaceutical experience in a pharmaceutical or biotechnology R&D setting
  • Familiarity with cardiovascular, metabolic, kidney, CNS, and/or rare disease programs
  • Prior experience preparing and submitting New Drug Applications to regulatory authorities
  • Deep knowledge of experimental design, clinical trial design or CMC statistics, drug regulation, and statistical function management
  • Extensive SAS and/or R experience
  • Strong written and verbal communication abilities
  • Experience selecting, contracting with, and managing CROs
  • Proven leadership and interpersonal skills, with the ability to earn trust and credibility within and outside the organization
  • Experience with adaptive and Bayesian study design simulation methods
  • Experience working in rare disease and/or gene therapy programs

Imtiyozlar

  • Opportunity for secondment to AskBio for a duration determined by Bayer and AskBio leadership, typically one to two years
  • Equal Opportunity Employer
  • Reasonable accommodation available for qualified individuals with a disability or disabled veteran

O‘xshash ish o‘rinlari

Cushman & Wakefield

Senior Manager, Data Engineering — Cushman & Wakefield (Remote, US)

Cushman & Wakefield
Malakali ishchi vizasi homiysiKonsaltingQurilishSog‘liqni saqlash
USAmerika Qo‘shma Shtatlari
140 250 $ – 165 000 $ / yil
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Senior Lead Data Engineer, Databricks

Booz Allen Hamilton
KiberxavfsizlikKonsaltingMudofaa
USAmerika Qo‘shma ShtatlariMDMerilendSCJanubiy Karolina
77 600 $ – 176 000 $ / yil
OfisdaTo‘liq stavkaSeniorTalab Qilinadigan Til: inglizchaMa’lumotlar muhandisi
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Lead the development of scalable Databricks data pipelines and models on AWS for Booz Allen Hamilton government clients. Guide technical teams and support secure data processing through hands-on leadership and mentoring.

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USAmerika Qo‘shma ShtatlariMDMerilendVAVirjiniya
77 600 $ – 176 000 $ / yil
OfisdaTo‘liq stavkaO‘rta darajaSeniorTalab Qilinadigan Til: inglizchaMa’lumotlar muhandisi
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Build scalable Databricks pipelines and analytics datasets for Booz Allen’s federal health and regulatory science work. Collaborate across technical teams to deliver secure data solutions that support mission-critical decisions.

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PNC

Lead Software Engineer, Data and Automation (MLOps)

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H1B vizasi homiysiBank ishiHR texnologiyalariMoliya
USAmerika Qo‘shma ShtatlariOHOgayoPAPensilvaniyaTXTexas
86 250 $ – 172 500 $ / yil
OfisdaTo‘liq stavkaSeniorTalab Qilinadigan Til: inglizchaMa’lumotlar muhandisi
AirflowApacheAWSAzureBulutHadoopKafkaKubernetesOpenShiftPythonSparkSQL

Lead development of data platforms, MLOps, and cloud automation at PNC. Build secure enterprise solutions using Azure, AWS, and modern data processing technologies.

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Regions Bank

Cloud Data Engineer, AI Platform — Regions Bank (Hybrid, Hoover, AL)

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H1B vizasi homiysiKonsaltingSog‘liqni saqlashSug‘urta
USAmerika Qo‘shma ShtatlariALAlabamaNCShimoliy Karolina
114 995 $ – 146 400 $ / yil
GibridTo‘liq stavkaO‘rta darajaSeniorTalab Qilinadigan Til: inglizchaMa’lumotlar muhandisi
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Build cloud data pipelines and AI applications for Regions Bank, supporting machine learning, analytics, and enterprise data systems. The role is hybrid in Hoover, Alabama.

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Henry Schein

Staff Data Engineer

Henry Schein
H1B vizasi homiysiIshlab chiqarishOziq-ovqat va ichimliklarSog‘liqni saqlash
USAmerika Qo‘shma ShtatlariWAVashington
150 000 $ – 165 000 $ / yil
MasofaviyTo‘liq stavkaYetakchiTalab Qilinadigan Til: inglizchaMa’lumotlar muhandisi
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Lead technical strategy for scalable data platforms, streaming, and analytics at Henry Schein One, supporting dental practice technology. Advance reliability and engineering practices while guiding technical delivery.

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