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Senior Biostatistician

India - Any Region - Home Based Date posted 04/17/2020 Job ID 55178BR

As a Biostatistician at Parexel you’ll work on a variety of projects, while collaborating with our global team of experts. You’ll be able to develop your statistical skills, gain exposure to multiple therapeutic areas, become involved in business development activities, and have the opportunity to grow and develop your career within a flexible working environment. You’ll also contribute to research design and analytical strategies, provide input into protocols, and develop and review statistical analysis plans.

  • Full Time
  • Level: Mid
  • Glassdoor Rating 3.5

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Analytical
  • Communicator
  • Leadership
  • Efficient
  • Tech-Savvy
  • Personable
  • "Parexel is very team oriented, so you work with a lot of people and also get to work in different therapeutic areas. There are many opportunities to find what you enjoy and the management is very supportive."

    James - Principal Biostatistician
  • "From a new graduate to a well-trained Biostatistician, I have definitely gained significant experiences in Parexel over the past three years. At Parexel I have always felt valued and supported, my strength got recognized and optimized here and my work got appreciated. I am very proud to be a part of the organization."

    Fiona - Biostatistician II


  • Career Development

    Opportunity to learn and grow through a performance and development goal-setting program.

  • Balance

    We value work-life balance. We try and keep regular hours and a flexible working enviroment.

  • Open communication

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Systems

    Utilize Parexel’s industry leading clinical systems and solutions

  • Mentoring program

    Strong mentors with depths of experience working for global health authorities.


The position serves as the primary statistical role with technical accountabilities plus coaching, mentoring and developing other statisticians and programmers.
The Principal Biostatistician is expected to provide broad statistical support, contribute strategically to project decisions with a focus on pre-study planning, protocol development, sample size / power calculations, Statistical Analysis Plan preparation/ review, data quality reviews, development of tables / listings / figures, preparation / mapping of clinical study data for regulatory submission.
The Principal Biostatistician is expected to have an understanding of advanced statistical methods and to research complex and innovative statistical approaches (e.g, modeling and simulation, adaptive design / Bayesian statistics) and mentor junior staff in the use of these approaches.
The professional will participate in meetings and teleconferences and also provide consulting, interpretive and analytical support to Clients.
Review publications and clinical study reports. Assist with the technical details of client proposal documents.
Represent PAREXEL at client marketing and technical meetings.
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.
Prioritise effectively and respond to urgent requests within internal group and the Client.

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.

Prior experience communicating with and presenting to the U.S. (FDA) and European Regulatory Authorities.
Prior experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submissions.


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).

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