2. Required Qualifications and Experience

2. Required Qualifications and Experience

Job Description- Senior Statistician


Principal Statistician and Director


  • PhD in mathematics, statistics or related disciplines
  • In depth knowledge and expertise in statistics and its applications to clinical trials and observational studies
  • Good knowledge of statistical software (SAS®, R, SPSS, STATA) and of data management principles and tools
  • At least five years of experience as a statistician in clinical development in pharmaceutical industry, clinicalresearch organization or equivalent experience
  • Knowledge of international clinical research regulations and requirements
  • Ability to work efficiently in an international team environment
  • Excellent interpersonal and communication skills
  • Must be able to work according to timelines and achieve project deadlines
  • Fluency in written and spoken English; knowledge of German and French beneficial but not required


  • Responsible for all statistical aspects of an observational study and/or clinical trial
  • Interacts with statisticians from health authorities to agree or defend decisions on statistical issues for thestudy
  • Informs and suggests solutions to the Company Head on critical issues within the study
  • Discusses the protocol and CRF with the authors and members of the clinical study team/trial team
  • Writes or supervises the writing of the statistical section of the protocol including the following:

Stating the hypothesis

Defining the planned analysis

Sample size calculation

Explaining the statistical basis for the choice of the sample size

Defining the primary and secondary variables

Defining the time periods

Defining interim analysis specifications, if applicable

Defining the intent-to-treat population, if applicable

  • Agree on details of the randomization schedule with the appropriate members of the project team, if applicable
  • Approves the randomization list, if applicable
  • Verifies the consistency of the protocol with the (e)CRF
  • Ensures that the study design is compatible with the trial objectives
  • Reviews and approves protocol and CRF prior to their use or submission to approval committees
  • Discusses, reviews and approves protocol amendments (as and when applicable)
  • Verifies the appropriateness of the planned analysis and writes or supervises the writing of the
  • statistical analysis plan
  • Assesses the impact of subjects withdrawn/lost to follow-up and impact of the deviations from plannedstudy/trial design
  • Assesses the impact of deviations from distribution assumptions, lack of homogeneity of treatment

arms, possible outliers etc.

  • Documents the methods and procedures used in the analysis
  • Assists in programming and/or validation where appropriate
  • Performs or supervises statistical analyses and discusses the results and the presentation of the

results with appropriate team members

  • Ensures that all statistical deliverables are verified and provided to the appropriate team members
  • Writes or supports the writing of the statistical section/module of reports (FSR, integrated

safety/efficacy reports and publications, interim report for PASS studies), including reviewing and approving the reports

  • Maintains up-to-date project and trial documentation including that of presentation and analyses
  • Verifies adherence to statistical standards and SOPs within the study/trial
  • Supports and leads continuous development and improvement of statistics and programming


  • Ensures appropriate statistical planning, analysis and reporting of one or more assigned clinical

studies, observational studies, development programs or drug submission dossier

  • Performs role of mentor for statisticians, statistical programmers and trainees
  • Reviews and anticipates resource requirements for existing projects
  • Provide resource plans and timelines for deliverables for assigned projects
  • Maintain / develop a high standard of statistical methodology through continuing education