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Senior Biostatistician

Bloemfontein, Orange Free State, South Africa Date posted 02/03/2020 Job ID 57186BR

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

Rewards

  • 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.

Responsibilities

The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact. The person will be recognized internally and externally as a statistical expert.

Key Accountabilities will include:-

- Operational Execution
* Provide broad statistical support, including trial design, protocol and CRF development on specific studies
* Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
* Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols
* Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans
* Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review

- Business Development
* Support of Business Development, eg. by actively contributing to 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

- General Activities
* Understand regulatory requirements related to the specific therapeutic areas &the implications for statistical processing & analysis
* Understand, apply and provide training in extremely advanced and sometimes novel statistical methods
* Contribute to the development and delivery of internal and external statistical training seminars and courses
* Review position papers based on current good statistical practice
* Interact with clients and regulatory authorities
* Review publications and clinical study reports
* Travel to, attend and actively contribute to all kind of client meetings as appropriate (eg discussing analysis concepts, presenting and discussing study results)
* Additional responsibilities as defined by supervisor/manager.

Qualifications

Skills:
* Good analytical skills
* Good project management skills
* Professional attitude
* Attention to detail
* Thorough understanding of statistical issues in clinical trials
* Ability to clearly describe advanced statistical techniques and interpret results
* Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)
* Ability to work independently
* Good mentoring/leadership skills
* Good business awareness/ business development

Knowledge and Experience:
* Sound / Substantial experience experience with SAS programming at Senior Biostatististics level is essential (minimum 5 years experience)
* Knowledge of pharmacokinetic data is an advantage
* Competent in written and oral English in addition to local language

Education:
* PhD or MS in Statistics or related discipline is required

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