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The candidate will support the Head of Statistical Programming to continuously improve processes to conform to evolving industry standards and participate in the ongoing review and development of quality systems and processes, including CDISC implementation and other internal/external initiatives.
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Demonstrated problem-solving, analytical, and multitasking skills with a good understanding of clinical research, statistical programming and CDISC standards. Evaluates and recommends upcoming industry trends, best practices, cutting-edge tools, and novel programming approaches that leverage machine learning, simulation, robotic automation, metadata driven processes, artificial intelligence, and natural language processing.
RemoteExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Proficiency to manipulate data using R programming. R programming – ability to troubleshoot errors in R. Experience with CDISC format and safety dataset structure (e.g., adsl. Experience on SAS programming.
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Good knowledge of statistical programming languages (e.g., SAS, R, Python, etc. Thorough knowledge and understanding of standards development processes, focused on clinical data with a strong knowledge of CDISC, HL7, OMOP, ICH, ISO standards and an understanding of global privacy regulations.
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Demonstrated knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements. Develops and implements company Study Data Tabulation Model (SDTM) standards that support the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that supports the exchange of data, reporting, and analysis.
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Lead the statistical programming activities for regulatory submissions following CDISC standards. Hands-on statistical programming for CSR, publications, presentations, DSUR, IB, safety data review, and ad hoc analyses.
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Solid knowledge of SAS Programming language, Software Development Life Cycle and CDISC standards (SDTM & ADaM). Remote Principal Statistical Programmer needs 10 years Pharmaceutical/Biotech programming experience including macro/tools development experience.
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This position will work closely with the Vice President of Biostatistics and Executive Director of Data Management and Statistical Programming and other members of the clinical, pharmacovigilance and regulatory affairs teams to provide programming support across all programs.
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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.
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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.
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Drives ongoing development and improvement of industry standards and provides leadership to external professional activities and organizations, such as CDISC, Phuse, Transcelerate, SCDM, EDC users group, SAS users group, etc.
Full-timeExpandUpdated 20 days ago - UpvoteDownvoteShare Job
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Substantial experience in statistical programming using SAS, R, or other relevant programming languages within the pharmaceutical or biotech industry. Familiarity with industry standards such as CDISC data structures and guidelines for data submissions.
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Minimum 12-14 years of clinical data management and/or database or statistical programming experience in pharmaceutical industry or health related field. Has a demonstrated understanding of clinical data capture/management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC, EHR, eCOA, IRT, CDR, MDR, SCE and adjacent systems.
$236,000 a yearExpandUpdated 20 days ago - UpvoteDownvoteShare Job
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Understands regulatory requirements concerning industry technical standards (e.g., CDISC standards, 21 CFR Part 11, FDA requirements, electronic submission standards, etc.) Expert level SAS programmer with experience in delivering complex programming assignments, macros and analyses.
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10+ years statistical programming experience in biotech/pharmaceutical industry. You'll build strong collaboration with clinical development and study teams to identify and meet their needs for statistical programming support.
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