Biostatistician

il y a 2 semaines


Bruxelles, Région de Bruxelles, Belgique Telix Pharmaceuticals (EMEA) Temps plein

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States.

Our mission is to deliver on the promise of precision medicine through targeted radiation.


At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases.

You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.


About The Role


The
Biostatistician will contribute to the achievement of the company's strategic goals through establishing, leading and further developing the Telix biostatistics function to support the rational design, execution and associated data analysis of clinical studies across the asset development pipeline.


You will provide biostatistical support to the preparation of clinical protocols, conference abstracts and presentations, manuscripts for potential publication and other medical and scientific materials.

You will also establish and maintain strategic partnerships to support ongoing development of asset pipeline and enhancing scientific and academic profile of the organization.


Responsibilities:

  • Provide strategic statistical input to the preparation of clinical trial documents and reports, protocols, investigator brochures, scientific abstracts, peerreviewed manuscripts, and responses to requests from regulatory agencies, ethics committees and institutional review boards and other authorities and agencies
  • Work with the clinical science team to formalize statistical analysis plans and reporting specifications, devise and implement statistical analysis strategies, interpret and present statistical results on Telix internal studies and, when required, investigatorinitiated studies.
  • Establish and maintain strategic external collaborative relationships to drive Telix clinical development programs and act as ambassador in relevant forums to raise the scientific and academic profile of Telix Pharmaceuticals
  • Drive the growth and development of the biostatistics function within the organization.
  • Review and analyze safety reporting data, biomarker analyses and other routine and novel aspects of clinical trial reporting
  • Plan and execute computer data file structures and develop, manage, and maintain statistical databases. Oversee, or perform, when necessary, data entry and management
  • Evaluate statistical software packages, lead statistical and data entry teams where relevant. Work with relevant functional team members in contracted vendors and at sites
  • Represent the company in interactions with industry and academic partners, regulatory authorities, clinical research organization and other vendors as appropriate e.g., FDA meetings, bid defense meetings
  • Maintain knowledge to enable ongoing execution of function as biostatistics expert. Maintain working knowledge of the Telix clinical development pipeline

Qualifications:

  • Bachelor of Science with specialization in statistics, or Bachelor of Mathematics and statistics or other relevant qualification
    required:
  • Advanced degree specializing in statistical methods desirable
  • Minimum 5 years experience in biostatistics roles supporting clinical drug development in the pharmaceutical industry
    required:
  • Experience in oncology/radiopharmaceutical drug development desirable but not essential
  • Strong working knowledge of advanced statistical software packages desirable
  • Demonstrated ability to function in a collaborative, crossfunctional matrix environment to develop clinical assets
  • Strong organizational and interpersonal communication, writing and presentation skills
  • Ability to think and execute strategically in the context of clinical asset development
  • Ability to prioritize deliverables and manage time effectively

Why work at Telix?


We are a dynamic, fast-growing biopharmaceutical company where employees have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives.

This is an exciting time for Telix and we are looking for like-minded, passionate professionals to join us on the journey.


_ This role can be located in the United States(remote), Belgium, Switzerland or in the UK._

_ Agency support is not required for this role and no submissions will be considered._


At Telix, we believe
everyone counts,
we strive to be extraordinary, and
we pursue our goals with determination and integrity.

You will be part of an engaged and supportive group of colleagues who all have a shared
purpose:
to help people with cancer and rare diseases live longer, better quality lives.

Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have have hybri

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