Biostatistician

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von: Teoxane SA | localité: GenèveN: TeoxaneSA

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Biostatistician

Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has a total freedom of thoughts, action and innovation which makes the company unique.

In the frame of the growth of our business, we are looking for a:

Biostatistician

Main activities

The Biostatistician plays a critical role by providing statistical expertise and insights to support the clinical development team, ensuring that all statistical and programming deliverables meet the highest quality standard and are delivered in a timely manner.

  • Write or contribute to the development of the statistical analysis plan and statistical sections of the clinical protocols, including study design, statistical power and sample size calculations, subject randomization schemes
  • Provide expert statistical input and interpretation of results, data analysis, meta-analysis across studies, reporting and visualization
  • Coordinate and perform statistical oversight for outsourced studies and activities
  • Contribute and review the clinical study reports and statistical sections of regulatory submission dossiers
  • Develop the table, listing and figure specifications, program and validate tables and listings, write the statistical analysis report
  • Ensure adherence to ICH-GCP, FDA regulatory guidelines and internal SOPs
  • Participate in the development and maintenance of clinical study documents
  • Participate to vendors selection and RFP
  • Participate in the review of the internal SOPs for biostatistics

Your profile

  • Minimum MSc. or PhD in biostatistics, statistics, or related discipline
  • 1-3 years of experience in biostatistics and programming.
  • Strong statistical methodology knowledge and implementation
  • Proven experience in programming in SAS, other languages a plus
  • Knowledge of ICH-GCP, FDA guidelines, CDISC and 21 CFR Part 11
  • Good organizational and analytical problem-solving skills
  • Team player, looking to be part and contribute to the team success
  • Excellent interpersonal, verbal and written communication skills
  • Fluent in English and French

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