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Senior Principal Biostatistician

USA - Any Region - Home Based Date posted 03/09/2020 Job ID post-53662BR_4

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 Senior Principal Biostatistician leads production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents. The Principal Biostatistician provides expert level statistical support to the team, supports business development and interfaces with clients regularly.

Key Accountabilities:

· Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review

· Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, as well as mentoring/training biostatisticians during their first exposure to DMCs.

· Provide strong statistical support / advice, including trial design, protocol and CRF development on specific studies

· Perform sample-size calculations, generate randomization lists and write / QC statistical methodology sections for inclusion in study protocols

· Support of Business Development, e.g. by actively contributing / leading the statistical aspects of the study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings for potential studies, programs of work and FSPs.

· Participate in and contribute to project bids, including client presentations.

· Apply and provide training in extremely advanced and sometimes novel statistical methods

· Travel to, attend and actively contribute / often lead all kind of client meetings as appropriate (eg discussing analysis concepts, presenting, discussing and interpreting study results)

· Interact with clients and regulatory authorities, including representation at key regulatory meetings on behalf of the client

· A thorough understanding of regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis

· Author or review publications. Present internally on key publications of interest

· Recognized as an expert in a particular field (i.e. DMCs, Therapeutic area, statistical method[s]), throughout the Biostatistics department worldwide

· Frequently involved in leading / contributing to key initiatives throughout GDO

· Participate in committees, task force groups as needed.


Required Skills and Experience:

•PhD or MS in Statistics or related discipline with extensive experience

•10+ years of experience working in Industry – Biopharmaceutical or CRO preferred

•Thorough understanding of statistical issues in clinical trials

•Excellent Communication skills

•Highly proficient in SAS Programming analysis

•Excellent project leadership and management skills

•Thorough understanding of statistical issues in clinical trials

• Excellent mentoring skills

•Excellent business awareness/ business development

•Ability to clearly describe advanced and/or novel statistical techniques and interpret results

•Thorough understanding of regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)

•Excellent negotiation skills

•Client-focused approach to work.

EEO Disclaimer

PAREXEL is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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