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- Assesses the impact of subjects withdrawn/lost to follow-up and impact of the deviations from plannedstudy/trial design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