Principal BiostatisticianIndia, Remote Job ID R0000002321 Category Biostatistics
About this Role
Provide advise and expertise in statistical methods and techniques to internal Statisticians and
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.
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).