Ablynx

Ablynx is a biopharmaceutical company engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx is dedicated to creating new medicines which will make a real difference to society. Today, the Company has approximately 40 proprietary and partnered programmes in development in various therapeutic areas including inflammation, haematology, immuno-oncology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Genzyme, Merck & Co., Inc., Merck KGaA, Novartis, Novo Nordisk and Taisho Pharmaceuticals. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.

 

Biostatistician

Purpose of the Position:

Provide biostatistical input in the Ablynx’ research and development areas, starting from planning and designing activities, through defining and conducting data analysis, to the final interpretation and reporting of results. Contribute to the reliability, scientific quality and optimization of projects. Support programs from "target identification" to "compounds in development” by providing appropriate non-clinical statistical support, and ensures a high scientific level, both on statistical methods and on regulatory requisites.

Working Relationships:

  • Internal Contacts

The Biostatistician can identify and define opportunities for added value creation in Ablynx’ activities (research and development process in the non clinical projects) by interaction with scientists and project managers.. The department delivers the applicable and most suitable statistical approach with end responsibility towards technical execution and validity of the obtained result.

  • External Contacts

International experts

Statistical consulting companies

Key Responsibilities:

  • Task identification and definition: proactive and reactive identification and definition of statistical tasks in a project team environment.

    Most important activities:

    - Creative and accurate problem solving oriented input in pre-clinical project teams and ad-hoc technical items

    - Ensure an up-to-date knowledge of Ablynx’ activities and their challenges in a research and development perspective

  • Know-how in statistical methodology, its practical implementation and reporting of results.

Most important activities:

- Bring statistical expertise (design of experiments, data analysis and interpretation) through the use of state of the art statistical methods, selection of appropriate tools and ensuring the correct use and implementation of these tools in-and outside the biostatistics department

- Determine optimal design (in terms of time, cost efficiency, quality), randomization and sample size

- Perform formal statistical analyses in line with applicable regulatory requirements

- Implement quality by design through the drug development process

- Prepare reports that summarize the analysis of research data, interpret findings and provide conclusions; formally verify reports for statistical correctness

- Implement good statistical practice (design, quality output) to enhance the chance of success of the experiment and improves the outcome of the statistical analysis

- Transfer results to non statisticians in a comprehensive language

- Archive datasets, analyses and reports to establish a knowledge base and to ensure easy transfer

  • Training of Ablynx’ personnel in good statistical practice to ensure transfer of appropriate statistical methodology to Ablynx’ personnel (biostatistical value creation).

Most important activities:

-Promote a “statistical thinking” philosophy

- Give training courses (general or upon request)

- Update the established set of Best Practice Guidelines

  • Support of the biostatistics department

Most important activities:

- Translate project/service tasks into a defined statistical approach

- Review of statistical tasks performed by other biostatisticians

 

 Skills, expertise and contribution:

  • Accountability: Exercising Judgment/Impact of Decisions/Consequence of Error : enabling role, if wrong analysis than statistical base could be wrong with non-appropriate results leading to new experiments
  • Knowledge & application:Verbal and written communication and interpersonal skillsWork according to procedures, rules and regulations.Ability to work alone or in teams
  • In-depth knowledge in Non-clinical development
  • Good SAS programming skills, as well as experience with other study design and analysis software (e.g. R, JMP)
  • Professional use of the English language both written and oral
  • Comprehensive knowledge of statistical methods and applications in non-clinical study design and analysis.
  • Problem Solving & Innovation: problems are situated on the level of misuse, misunderstanding of statistical data and its added value by colleagues

Minimum Qualifications:

  • Expected educational qualifications: Master degree in a relevant field of life sciences, and additional Master of science in (bio) statistics or equivalent by experience
  • Expected experience: At least an (industrial) experience of 3 years (preferably in biotech or pharma)

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