Lead Biostatistician

ICON is looking for a Study Lead Biostatistican with Oncology experience to support one of our FSP programs!! 

Key Responsibilities:

• Perform all duties and responsibilities associated with the Study Statistician role
• Oversee the work performed by multiple Study Statisticians
• Review work performed by Study Statisticians and provide guidance to meet the study and project requirements
• Attend Clinical Study Team (CST) meetings and provide all required statistical input related to strategy and operations of the clinical study
• Plan and execute statistical contributions to Study Outlines,  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
• Assist in resource planning for assigned projects
• Be familiar with all Company’s policies, SOPs
• Assist with study and systems audits conducted by Company GCA and external bodies
• Stay abreast of latest developments in the field of statistics in drug development

Potential Responsibilities:

• 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 
• Lead and/or participate in the development and review of  Policies, SOPs and other controlled documents
• May lead and/or participate in change / process improvement initiatives 
• May participate in external activities (e.g., Industry, academic)

Basic Qualifications:

• Master’s degree in Statistics/Biostatistics or other subject with high statistical content with 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 with 3 years of post-graduate statistical experience in the pharmaceutical industry or medical research
• 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
• 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
• Excellent oral and written English communication skills
• Authored a protocol, DRT/DMC charter, SAP, CSR, or Research Project Plan (RPP)
• Strong knowledge of current CDISC standards for ADaMs
• Strong fundamentals of Project Planning and Project Management
• Demonstrated ability to immediately dive into detailed and/or complex projects
• Strong SAS programming skills in applying statistical procedures based on complex study designs

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
• Designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
• 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
• Leadership of at least 3 clinical studies/projects with minimal oversight
• Authored multiple protocols, DRT/DMC charters, SAPs, CSRs, and Research Project Plans (RPP)
• Strong capability of implementing current CDISC standards for SDTMs and ADaMs
• 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
• Development of policies and SOPs
• Experience in adaptive clinical trials
• Experience in the utilization of Bayesian statistics in clinical trials

Experience

• For Master’s degree: 6 years post-graduate experience in the pharmaceutical industry or medical research, 8 years preferred
• For Doctoral degree: 3 year post-graduate experience in the pharmaceutical industry or medical research, 5 years preferred