Principal Biostatistician

Key Accountabilities
 Provide advise and expertise in statistical methods and techniques to internal Statisticians and
Programmers.
 Represent Biostatistics and Parexel.
 Participate in business development.
 Act as key contact regarding customer relationship management activities.
 Establish and maintain sound working relationships and effective communication with Clients
and global Early Phase biostatistical group.
 Organise and participate in Client and team meetings.
 Identify and facilitate training needs in collaboration with Line Managers.
 Manage quality issues.
 Monitor productivity.
 Participate in preparation of audits / inspections, audits and any follow up activities.
 Awareness of Revenue Recognition and associated tasks and timelines.
 Effectively communicate with internal and external customers as well as third party vendors.
 Prioritize effectively and respond to urgent requests within internal group and the Client.
Skills  Experience in all tasks of a Trial Statistician.  Proven knowledge in Statistics and its applications to clinical trials.  Proven knowledge of statistical software packages.  Good communication and presentation skills.  Possess strong negotiation, diplomacy, team leadership skills and excellent organizational ability.  Excellent interpersonal, verbal and written communication skills.  Ability to identify and address issues proactively in a timely manner.  Ability to make appropriate decisions in ambiguous situations.  Carefully weighs the priority of project tasks and directs team accordingly.  Excellent computer literacy.  Demonstrate a sound knowledge of all relevant regulations, including GCP.  Good team player. Education  A Ph.D. degree or equivalent in statistical science, mathematical analysis or related field plus 4 years relevant experience or a master’s degree plus 6 years relevant experience.  Comprehensive knowledge of statistical theory and methods and demonstrated ability to apply it to all phases of clinical trials.  Expertise in SAS programming including statistical analysis, data manipulation and scientific graphing.

 Demonstrated knowledge of all relevant statistical regulatory guidance and standards (e.g, FDA, ICH and EMA).