Lead Biostatistician

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