Trainee in CMC Statistics

  • Idorsia Pharmaceuticals Ltd
  • Basel, BS, Switzerland
  • 27/05/2022
Full time Data Science Business Intelligence Statistics Biostatistics

Job Description

Job details

Job Type
Full-time
Temporary / Staffing

Full Job Description

About Idorsia Pharmaceuticals Ltd
Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,100 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for an enthusiastic and motivated Trainee in CMC Statistics to join our team

Job Responsibilities

  • Create ready-to-use templates to be used by non-statisticians (pharmacists, engineers, technicians) about :
  • Confidence/prediction/tolerance intervals
  • Settings specifications
  • Expected acceptance limits
  • Shelf life estimation
  • Setting of specifications
  • Uniformity of dosage units
  • Blend uniformity
  • Dissolution
  • Authoring of sections about data statistical analysis in development and commercial protocols and reports as well as SOPs :
  • Manufacturing process validation for solid oral dosage forms, parenteral forms, devices for combination products
  • On-going process verification: sample size adaptation, frequency of sampling based on already generated results.
  • Statistical rules for monitoring process performance and predictability
  • Statistical rules to apply at different steps of device development: design verification, design validation and release testing
  • Statistical data analysis Subject Matter Expert within GPDQA
  • Act as a Subject matter expert” to support projects or other GPDQA initiatives requiring statistics know-how
  • Organize on-demand workshops on use of statistical tools (Minitab, excel templates….)

Candidate’s Requirements

  • Academic degree in statistics, knowledge in pharmaceutical sciences is an asset.
  • Personality and disposition to work in teams
  • Good communication, curious, flexible, pragmatic and results-orientated
  • Good knowledge in statistics: e,g,, DoEs, sample size definition, statistical comparability tests and validity,
  • Fluent in English; ability to communicate in German and French would be an advantage
  • Experience with programming languages e.g. SAS or R and in statistical or DoE software e.g. Minitab, MODDE etc..

What Idorsia offers

  • Exciting opportunities for development and professional growth within our dynamic organization
  • A collaborative and solution oriented enviroment where you can make a difference
  • An innovative and open culture in a truly multicultural environment

Work Location: Allschwil
Country: Switzerland
Business Area: Global Pharmaceuticals Development and Quality Assurance - Drug Product Development
Schedule: Fulltime
Job Type: Temporary for one year
Job Id : 3470

At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success.
We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. All applicants will receive consideration.
We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates, or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.