Principal Biostatistician (BB-E0188)
Found in: Neuvoo AU
Job Description:Parexel is one of the world’s top 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 Principal Biostatistician, you will lead research design and analytical strategies, input into protocols, develop and review statistical analysis plans and author/co-author reports, abstracts and manuscripts and provide statistical advice. You will input into the quality control of statistical deliverables. As the Functional Lead within a study team, you will lead the biostatistical and statistical programming activities on a study and be accountable for the deliverables from these functions. Key responsibilities also include; project management of deliverables, resource and function-specific budget. You will have the opportunity to become a subject matter expert for specific tasks within key client partnerships and to become involved in business development activities.We are aiming to expand our Biostatistics and Statistical Programming team in Australia, and are currently recruiting for a Principal 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 (Senior Biostatistician) or one level above (Senior Principal Biostatistician) the position advertised. Job Overview• Provide broad statistical support, including trial design, protocol and CRF development on specific studies.• Lead production and quality control of randomization, statistical 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.• Support of Business Development, e.g. 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.• Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and 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 (e.g. discussing analysis concepts, presenting and discussing study results)QualificationsEducation/Qualifications• PhD or MSc in Statistics or related discipline with extensive experienceExperience• Significant experience in the design and analysis of clinical trials. • A thorough understanding of the statistical aspects of clinical trials.• Experience with observational studies/outcomes research would be beneficial.• You ideally have advanced SAS programming skills, but this is not necessarily essential.• Confidence, be self-reliant and a quick learner who enjoys working in a matrix team.• Strong oral and written English communication skills.• Ability to travel as required to Client meetings and to support sales activities.
calendar_today6 days ago