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June

Ad, Biostatistics

Planet Pharma - West Arnhem, NT

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

Job Description

We are currently seeking, a motivated Associate Director, Biostatistics to become a part of the growing Biometrics (Biostatistics, Statistical Programming, and Clinical Data Management) team. The successful candidate will provide statistical leadership and technical expertise in support of clinical development activities for early and late development programs with a focus on immunology therapeutic area. The individual will be responsible for all aspects of biostatistics activities of the clinical trials and decision making, including overall clinical development plan, trial design, protocol development, analysis planning, sample size/power calculations, independent data analysis for quality control, interpretations of results, go/no go decisions, preparation of regulatory submissions and interactions, and publications. The individual will collaborate with cross-functional teams including statistical programming, clinical operations, clinical development, statistical programming, translational research, regulatory, and other functions. The individual will serve as an internal expert in the overall programs and will manage vendors for outsourced statistical and programming related activities to ensure highest quality of all deliverables within the budgets and timelines. The individual will lead or participate in the long-term growth strategy of the department, including process improvement, standardization, SOP development, and statistical methodology development.

  • Serve as the lead statistician for all biostatistics deliverables across clinical development programs through own effort and/or management CROs.
  • Collaborates with project team members and leads or manages CROs to generate clinical protocol, review/author statistical analysis plan/TFL templates, programming specifications, CRFs, and CRF edit checks, CDISC data sets and CDISC data set specifications, supports and participate in the preparation of clinical study reports, regulatory submissions, annual DSUR and safety reports and publications.
  • Oversees or performs ad-hoc and exploratory analysis, confirm accuracy and appropriateness, interpret study results for internal decision making.
  • Effectively manage CROs to ensure high-quality deliverables within timeline and budget.
  • Lead in development and adaptation of novel statistical methodology in support drug development.
  • Participate or lead Biometrics Department Initiatives such as department tools, templates, guidelines, and SOPs.
  • Maintains consistently high-performance standards and quality of work and ensures all clinical development programs meet scientific, regulatory, quality and commercialization requirements.

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

West Arnhem, NT

Health, Medical & Pharmaceutical




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