Statistician CMC Development

UCB

Braine L'alleud, Belgium

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UCB aspires to be the patient-centric global biopharmaceutical leader transforming the lives of people living with severe diseases. We focus on central nervous system and immunology disorders. Our promise is to help tackle the serious unmet medical needs affecting patients around the globe. An important part of our philosophy is to take a holistic approach to patients, which aims to find solutions tailored to their circumstances. By taking into account patients’ individual characteristics and lifestyles, such as age, diet, family history and genetic profile, we are also coming closer to providing personalized therapies.

Within the Global Technical and Industrial Solutions Department, for our Braine L'alleud based team, we are now looking for a (m/f)

Non – clinical CMC Statistician

Job nature and scope:

Provide statistical support to the Technical and Supply Chain Operations (TSO ) department . Provide troubleshooting support in line with TSO business needs. This position provides statistical expertise for the design and analysis of processes of NCE and NBE's (drug substance and drug products) as well as laboratory procedures and experiments. The role is integrated within projects to drive greater understanding and insights from collected data, enabling clear, defensible and timely data-driven decisions and actions, accelerating project completion and supporting submission files.

Major Accountabilities:

  • Provide statistical expertise to nonclinical CMC drug development activities, with a focus on technical operation including assay development, bioprocess development, quality control, and manufacturing.
  • Propose experimental design and analysis strategies, perform statistical analyses, and collaborate with investigators to ensure the statistical integrity of nonclinical reports.
  • Support regulatory submissions and investigations.
  • Build strategic partnerships with collaborators and promote statistical thinking in decision making in nonclinical areas of drug development.
  • Develop and deliver statistics courses to nonclinical audiences
  • Collaborate with scientists in support of external publications.
  • Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and professional activities.

Education, experience and skills:

  • Ph.D. in statistics or biostatistics with at least 2 years of experience or a master’s degree in statistics or biostatistics with at least 4 years of experience as statistician in product development within the pharmaceutical industry
  • Other industry experience (pharmaceutical in clinical or preclinical, Chemistry industry, Food industry) may be considered
  • Excellent understanding of theoretical and applied statistics.
  • Statistical consulting skills combined with excellent problem-solving skills.
  • Experience with statistical software packages such as R, SAS, and JMP.
  • Effective oral and written communication skills.
  • Ability to work independently on multiple projects.
  • Fluent in English and French

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