Principal Biostatistician

1 week ago

REMOTE, India Parexel Full time
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).
#LI-REMOTE

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