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February

Principal Biostatistician

Parexel - Australia,

Biotech, R&D, Science
Source: uWorkin

Source: uWorkin

JOB DESCRIPTION

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
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Analytical
Communicator
Leadership
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Tech-Savvy
Personable
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.

Job Description:
Parexel is one of the world’s leading Contract Research Organizations, providing a suite of biopharmaceutical services that help pharmaceutical and biotech clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.

As a Senior Biostatistician, you will be the Biostatistics Lead on studies, responsible for the biostatistics and statistical programming activities of projects. This includes developing the statistical methods section of protocols, preparing analysis plans and writing the specifications for analysis files, tables, listings and figures, performing quality control of datasets and outputs, and writing statistical sections of reports. The Biostatistics Lead serves as the point-of-contact for customers with responsibility for building and maintaining client relationships. Within Parexel, you will work with study teams to ensure high quality deliverables, delivered on time and within budget.

Besides core biostatistics work, other responsibilities include project management of deliverables, financial management of projects, support of management to understand resourcing demands, and commenting on proposals and budgets at a study level. You may work on a specific client portfolio, or support multiple clients, depending on business needs.

We are aiming to expand our Biostatistics and Statistical Programming team in Australia, and are currently recruiting for a Senior Biostatistician for either a home or office based (Macquarie Park, NSW) position. Depending on skills and experience, we open to hiring at one level below (Biostatistician II) or one level above (Principal Biostatistician) the position advertised.

Job Overview
Lead production and quality control of statistical analysis plans, TFL shells, statistical reports, and statistical sections of clinical study reports.
Partner with the Statistical Programming Lead for the production and quality control of analysis datasets and tables, listings, figures.
Perform sample-size calculations, review 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.
Review and provide input into key deliverables/documents drafted by other departments, including the case report form, protocol deviations specification, project management plan and risk management plan.
Support of Business Development, e.g. by reviewing and commenting on proposals and budgets, and presenting at bid defense meetings.
Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis.
Help to train staff and may be expected to act as a subject matter expert (SME).
Interact with clients and internal project teams.
Travel to, attend and actively contribute to all kind of client meetings as appropriate.
Qualifications
Education/Qualifications
PhD in Statistics with some experience or MSc in Statistics with significant experience

Experience
Approximately 3-5 years experience in the design and analysis of clinical trials.
A thorough understanding of the statistical aspects of clinical trials.
The knowledge of pharmacokinetic data would be beneficial.
Prior experience with SAS programming required
Works independently with attention to detail and good project leadership skills.
Strong oral and written English communication skills.
Ability to travel as required to Client meetings and to support sales activities.