Principal Biostatistician

This position will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies.  

The position is accountable 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.

The program of studies will typically lead to a regulatory submission.

·         Biostatistical input into the clinical development plan of the program 

·         Protocol input such as study design, sample size calculations and patient randomization schemes

·         Statistical aspects of case report form design

·         Reviews study database structures, edit checks and data management coding conventions

·         Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports

·         Statistical analyses

·         Interpretation of data and reporting of results

·         Writing of the statistical methods sections of integrated study reports

·         Integrated summaries of safety and efficacy

·         Supports responses to regulatory questions on the design the design of the program, and any labelling claims following submissioLiaises regularly with programming study/program leads to ensure support on key discussions (timelines…etc.) and early warning to senior management of programming issues (resource/project issues...etc.)

• Liaises regularly with the programming program lead to ensure program level programming solutions are being identified and implemented.
• Ensures that all work is carried out in accordance with ICON SOPs. Develops program specific procedures (SSPs) as required and ensures that team members adhere to the SSPs.
• Documents and archives analysis and programming work to ensure a complete audit trail.  Participates in the setting of program level document standards.
• Creates and maintains biostatistics files for the program and each study.

In addition to the requirements outlined above, the Principal Biostatistician will perform the following tasks:

·         Establishes and maintains effective working relationships with clients and ICON project team members, including data management personnel, statistical programmers, and clinical research personnel.

·         Participates in presentations at client and investigator meetings.

·         Preparation of biostatistics input to ICON research proposals, participates in proposal defense meetings and makes presentations at marketing meetings with prospective client. 

Requirements

·         Degree in statistics, biostatistics, or related field

·         Significant experience in the Pharmaceutical industry