2. Required Qualifications and Experience

Job Description- Senior Statistician

1. REPORTS TO

Principal Statistician and Director

2. REQUIRED QUALIFICATIONS AND EXPERIENCE

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

3. RESPONSIBILITIES AND TASKS

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Assesses the impact of subjects withdrawn/lost to follow-up and impact of the deviations from plannedstudy/trial design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

processes

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