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The Head of Biopharma Biostatistics serves as a leader within the global biostatistics department responsible for strategic and operational oversight of the biostatistics and statistical programming activities for Emmes biopharma portfolio in key therapeutic areas such as vaccine and infectious diseases, ophthalmology, CNS, rare disease and cell and gene therapy among others.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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PhD, ScD or DrPH in Biostatistics or related field with emphasis on applied statistical methodology. Must have sound knowledge of relevant clinical and statistical regulatory requirements (e.g., GCP, ICH, CDISC, FDA, and other requirements.
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Good understanding of standards specific to clinical trials such as CDISC, SDTM, ADaM, MedDRA, WHODRUG. BS/MS in Statistics, Biostatistics, Computer Science, Mathematics or Life Sciences - 10+ years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
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Collaborates with Clinical Operations, Data Management, Clinical Development, Drug Safety, Statistical Programming, and Biostatistics to develop standard and custom data reports for quality data oversight / clinical data review.
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Lead and manage external (and/or internal) biostatistics and statistical programming resources supporting studies and programs. He/She is also accountable for the production of biostatistics deliverables by providing oversight of the work performed by CROs, managing external (and/or internal) biostatistics and statistical programming resources, or performing the work themselves.
$220,000 - $260,000 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Demonstrated understanding of CDISC and SDTM requirements and implementation guidelines, able to create and validate CDISC standard datasets. Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
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Proficient SAS & R programming skills, solid understanding of CDISC models and standards. Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC standards.
$148,000 - $194,250 a yearFull-timeRemoteExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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ClinChoice is a global CRO supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide.
Full-timeRemoteExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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The Senior Principal Statistician, Biostatistics will be a lead statistician on individual studies, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician.
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As a Principal Statistical Programmer , you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials.
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This position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence projects across our company's Biostatistics and Research Decision Sciences (BARDS) group.
$130,960 - $206,200 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Key Responsibilities The role of the Sr. Statistical Programmer is to oversee and/or contribute to the delivery of the in-house deliverables including CDISC conversion; statistical programming contributions provided by Contract Research Organizations for clinical trials; to provide planned, ad hoc and exploratory statistical programming services including quality control; and to help create departmental systems, standards, and processes.
Full-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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For over 34 years we have embraced innovation when offering services in Pharmacovigilance, Biostatistics, Data Management and Custom Database Solutions. Solid knowledge and application of CDISC, SDTM and ADaM submissions.
ExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Experience with industry data standards, including CDISC, SDTM, CDASH, ADAM, and their implementation in statistical programming. R, regression analysis, Hypothesis testing, SAS, Clinical Research, biostatistics, statistical programming.
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Detail-oriented with a commitment to producing high-quality deliverMaster's or Ph. D. in Biostatistics, Statistics, or a related field with a strong emphasis on pharmacokinetics (PK) and pharmacodynamics (PD) tables within tight timelines.
$111,400 - $203,100 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago
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