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Position: Study Lead Statistician – Safety Surveillance
Institution: Spectraforce Technologies, Inc.
Location: United States
Duties: Assist in the development of statistical methodologies to aid the routine evaluation of cumulative safety data at the individual clinical study level as well as accumulating data across multiple clinical studies; Stay abreast of latest developments in the field of statistics in drug development and regulatory guidance, in particular of the field of ongoing clinical study safety data review; Assist in the development of processes, controlled documents, methodology and utilities to aid in the routine evaluation of cumulative safety data; Provide statistical support to the safety team and the biostatistics safety team for safety signal detection; Hands on data exploration, analyses and potentially utility development (eg. RShiny); Working as a member of the Centralized Statistical Monitoring (CSM) team you will be responsible for delivering CSM across multiple studies
Requirements: Master’s degree in Statistics/Biostatistics or other subject with high statistical content with at least 3 years of post-graduate statistical experience in the pharmaceutical industry or medical research; Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing); Designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia; Demonstrated ability to immediately dive into detailed and/or complex projects including researching and applying new statistical methodology; Independent leadership of the design, analysis and reporting of at least 3 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
   
Text: Study Lead Statistician - Safety Surveillance Job Description Study Lead Statistician - Safety Surveillance Duration 6 months Remote “Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at client. In accordance with applicable law, Client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to client, its operations, or its staff.” The Study Lead Statistician (SLS) for Safety Surveillance is responsible for working closely with the Client Safety biostatistics team and Client Global Patient Safety to monitor the safety of the products Client through a variety of techniques for ongoing safety assessment - they will assist in the development of statistical methodologies and processes that will ultimately result in the development of utilities to aid in the routine evaluation of cumulative safety data at the individual clinical study level as well as accumulating data across multiple clinical studies. In addition the Study Lead Statistician will provide statistical support to the Centralized Statistical Monitoring (CSM) team - assist with review of CSM signals, process improvements and new signal development through hands-on data exploration and analyses. They will also be an active member of the CSM statistics team and cross functional CSM team. Key Responsibilities: • Assist in the development of statistical methodologies to aid the routine evaluation of cumulative safety data at the individual clinical study level as well as accumulating data across multiple clinical studies • Stay abreast of latest developments in the field of statistics in drug development and regulatory guidance, in particular of the field of ongoing clinical study safety data review • Assist in the development of processes, controlled documents, methodology and utilities to aid in the routine evaluation of cumulative safety data • Provide statistical support to the safety team and the biostatistics safety team for safety signal detection • Hands on data exploration, analyses and potentially utility development (eg. RShiny) • Working as a member of the Centralized Statistical Monitoring (CSM) team you will be responsible for delivering CSM across multiple studies • Design of new pragmatic algorithms for detection of clinical data quality potential issues • Assist in the development of Quality Tolerance Limits (QTLs) including development of the Company’s policy and other controlled document • Review work performed by Study Statisticians and provide guidance to meet the study and project requirements • Assist in resource planning for assigned projects • Be familiar with all Company’s policies, SOPs and other controlled documents related to all study activities performed • Be familiar with statistical policy and strategy at Client • Assist with study and systems audits conducted by Company GCA and external bodies • Contribute to scientific advances in the field within Client Potential Responsibilities: • 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 Client Policies, SOPs and other controlled documents • May lead and/or participate in change / process improvement initiatives within Client • Perform all duties and responsibilities associated with the Study Statistician role • Oversee the work performed by multiple Study Statisticians • May participate in external activities (e.g., Industry, academic) • May serve as a subject matter expert within a specified field of statistics internally and/or to external collaborators Required Qualifications: • Master’s degree in Statistics/Biostatistics or other subject with high statistical content with at least 3 years of post-graduate statistical experience in the pharmaceutical industry or medical research • Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing) • Designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia • Demonstrated ability to immediately dive into detailed and/or complex projects including researching and applying new statistical methodology • Independent leadership of the design, analysis and reporting of at least 3 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia • Strong SAS or R programming skills in data derivation and application of statistical procedures • Strong skill in communicating statistical information clearly and concisely (written and oral) • Strong understanding of statistical concepts related to the design and conduct of clinical studies • Strong ability to apply statistics in the analysis of clinical trials • Excellent oral and written English communication skills Preferred Qualifications: • Master’s degree in Statistics/Biostatistics or other subject with high statistical content and at least 5 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 • Strong understanding of Bayesian methodology • Experience in the utilization of Bayesian statistics in clinical trials • Authored a protocol, DRT/DMC charter, SAP or CSR • Experience in assisting the safety team with aggregated analysis for signal detection for ongoing studies • 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 • Software Development Life Cycle experience • Strong fundamentals of Project Planning and Project Management • Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions, working with clinical development colleagues in study management, programming and IS • Demonstrated ability to influence decision making • Development of policies and SOPs SAY HELLO TO NEWJOBPHORIA. 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