Study Lead Biostatistician

About the Role ICON is seeking a Study Lead Biostatistician to design and analyze clinical trials, interpret complex medical data, and contribute to the advancement of innovative treatments. The role involves leadership of study design, analysis and reporting, with responsibility for at least one complex study (or multiple less complex studies) within the Pharmaceutical/Bi Biotechnology/Public Health setting. This position sits in the Biosimilars group. What You'll Do

• Independently lead the design, analysis and reporting of at least 1 complex study (or multiple less complex studies) within the Pharmaceutical/Bi Biotechnology/Public Health setting in Industry, Government or Academia.
• Provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements.
• Present results and defend statistical findings, study design and analysis to internal study/product teams or external meetings such as investigator meetings, steering committees, ad boards or regulatory meetings.
• Demonstrate excellent oral and written English communication.
• 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.
• Ability to immediately dive into detailed and/or complex projects.
• Strong SAS programming skills in applying statistical procedures based on complex study designs.
• Perform all duties and responsibilities associated with the Study Supporting Statistician role.
• Oversee the work performed by multiple Study Supporting Statisticians; review work and provide guidance to meet 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, SAPs, TLG shells, 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 and other controlled documents related to all study activities performed.
• Be familiar with statistical policy and strategy.
• 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. What We're Looking For
• 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. Compensation & Benefits ICON’s offerings include a competitive salary and a range of benefits designed to support well-being and work-life balance:
• Various annual leave entitlements.
• Health insurance offerings.
• Competitive retirement planning offerings.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of professionals.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
• Visit our careers site to read more about the benefits ICON offers.

We foster an inclusive and accessible environment for all candidates, and all qualified applicants will receive equal consideration for employment.