Biostatistician (telecommute)
DOCS - San Diego, CA

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Job Description

1 year extendable contract, 100% work from home.

Sr. Biostatistician

Basic Qualifications:
• Master’s degree in Statistics/Biostatistics or other subject with high statistical content, and 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Or
• Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 3 years of post-graduate statistical experience in the pharmaceutical industry or medical research
• Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
• Demonstrated ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements
• Demonstrated ability in presenting results and defending statistical findings, study design and analysis. This could be to internal audiences (study/product team) or at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings
• Demonstrated effective communication skills (written and oral)
Preferred Qualifications:
• Master’s degree in Statistics/Biostatistics or other subject with high statistical content, and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Or
• Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research
• Demonstrated ability in presenting results and defending statistical findings, study design and analysis to internal audiences (study/product team) and at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings
• Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
• Statistical contributions to regulatory and/or reimbursement submissions
• Demonstrated ability to influence decision making
• Project Planning and Project Management
• Development of policies and SOPs
• Implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis
• Plan and execute statistical contributions to Study Concept Documents (SCDs), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph ( TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, product plans (e.g. Global Development Plan), Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), regulatory documents, reimbursement documents and other communications
• Complete statistical analysis of multiple studies/projects
• Hire, manage and develop statistical staff
• Contribute to resource and budget planning
• Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)
• Be familiar with statistical policy and strategy at client
• Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field
• Promote and communicate statistical awareness and the role of the Global Biostatistics department, and may contribute to statistical consultancy, statistical training and expert advice within Global Biostatistics and within client
• Lead and/or participate in the development and review of Policies, SOPs and other controlled documents
• Participate in study and systems audits conducted by client GCA and external bodies, and respond to audit questions and findings
• May lead and/or participate in change / process improvement initiatives
• May participate in external activities (e.g., Industry, academic)

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