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Principal Biostatistician

Employer
ICON Plc
Location
Ireland, United Kingdom, Homeworking
Salary
Competitive
Start date
23 May 2023
Closing date
7 Jun 2023

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Job Details

Principal Biostatistician - Oncology

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

ICON has an exciting opportunity for a Principal Biostatistician to lead a portfolio of oncology studies in ICON's Operational Centre of Excellence (IOD) focusing on delivery and efficiency of our pharmacovigilance, data management, biostatistics, programming and medical writing services, which will leverage our expertise and best practices to produce top-quality output.

The Principal Biostatistician role is an exciting opportunity to be a critical part of the development of cutting-edge science to help our clients create transformative medical technologies for patients. Lead, plan, monitor, organize, and review activities of a team of biostatisticians and programmers working on a program of studies. Provide protocol input, sample size calculations, patient randomization schemes, and statistical aspects of case report form design.

Come join a collaborative team working to solve the world’s leading health challenges.

Overview of the role:

The Principal Biostatistician will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of moderate complexity and/or of high value with high impact for the organization. Also responsible for planning, monitoring, organizing, and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to required quality. Accountabilities also include maintenance of consistency across studies.

  • Biostatistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design
  • Review project database structures, edit checks, and data management coding conventions
  • Preparation of statistical analysis plans (SAP) including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports
  • Statistical analysis, Interpretation of data and reporting of results
  • Writing of the statistical methods sections of integrated study reports; reviews draft integrated study reports
  • Supports responses to regulatory questions on the design of the program, and any labelling claims following submission
  • Participates in presentations at client and investigator meetings
  • Preparation of biostatistics input to ICON research proposals, and participates in proposal defense meetings, and makes presentations at marketing meetings with prospective client


To be successful, you will need:

  • M.S. or Ph.D. degree in statistics, biostatistics, or related field (required)
  • 8+ years of relevant experience with M.S. OR 7+ years of relevant experience with Ph.D. (with at least 6-8 years of experience in the pharmaceutical industry)
  • Excellent verbal and written communication skills
  • In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas
  • Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must
  • Oncology experience is required for this role
  • Prior experience interacting with sponsor/clients
  • Experience leading Phase II and/or Phase III studies


Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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