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Biostatistician - biotech - Charleroi

Company

Our client is a clinical stage biotech company leading the development of new therapies for rare diseases. The company’s leading program involves the treatment of X-linked Adrenoleukodystrophy, a fatal neurodegenerative disease affecting both pediatric patients and adults. Minoryx’s treatment could become the first approved treatment for the most prevalent form of the disease.

The company is now preparing for presenting a marketing authorization application (MMA) in Europe while in the US is under discussions with FDA on the path to approval. The company recently secured one of the largest rounds of EU biotech in 2022. The headquarters is located near Barcelona in Spain and this position will be located in the subsidiary near Charleroi.

Role

As the company is growing, we are currently looking for a Biostatistician. You will report to the Director of Clinical Operations.

This position is an excellent opportunity to contribute actively to the advancement and the growth of a Phase 3 stage company while contributing to the development of a promising treatment for a rare disease with a high unmet medical need.

As a biostatistician, you will have multiple tasks such as:

Preparation of the study project

  • Elaborate the statistical section of the clinical trial synopsis and protocols. Calculation of the sample size and deciding which statistical analyses should be performed for the primary and secondary endpoints of the clinical trials.
  • Supervising the statistical analysis plan (SAP) prepared by the CROs who support Minoryx in the performance of the clinical trial.
  • Supervising the CRO programming and outputs generated for each clinical trial.
  • Coordinate service providers: scientific organisations, data suppliers, statistical experts, CROs.

Exploitation of data and production of results

  • Exploiting the scientific data collected, extracting useful data.
  • Carry out tests (consistency, cohesion) or statistical learning and the necessary application adjustments.
  • Carry out data analysis in a descriptive form.
  • Interpret the results and translate them into statistical form.

Writing and publishing results

  • Validate and write the statistical part of the clinical documents: study outline and protocol, statistical analysis plan and report, scientific publications.
  • Ensuring the presentation of statistical results to the health authorities in support of regulatory dossiers and in professional events.

Methodological monitoring

  • Ensure a prospective watch on scientific studies, programming methodologies and new tools.
  • Follow scientific and technical news.
  • Participate in professional exchanges in your speciality.

Profile

  • Bachelor/Master degree in (Bio)Statistics, Mathematics, Natural sciences or Health related field.
  • At least 3 years of experience as a Biostatistician
  • Experience in clinical trials
  • Knowledge of CDISC standards (ADAM) is a plus, not mandatory
  • Familiar with SAS
  • Previous experience in a Biostats department of a pharma/biotech/Stats department of a CRO
  • Autonomous
  • Sense of organization
  • Accuracy and attention to detail
  • Ability to work independently
  • Fluent English
  • Good communication skills

Offer

  • A dynamic and ambitious work environment in a high qualified and experimented small team, with daily interactions with the headquarters in Spain
  • Permanent contract, full time job
  • Location: Gosselies + 2 days teleworking/week
  • Start date: ASAP

Publication date

03.08.2022

Contact person

Leonard

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