Rosemind consulting b.v. -  Amsterdam
5 dagen geleden   |   22x bekeken

Functie omschrijving

Job Purpose:

To provide statistical expertise to support different clinical trial designs in a top bio-pharmaceutical company.


Key Responsibilities:

Responsible for a whole study from design to execution for different study designs:


- Use stat methodology to establish study strategy (e.g.  power modelling of different scenario, set up power monitoring, set up mitigation plan to minimize risk of stat failure) 

- Provide input to protocol (design, objective, endpoint, randomization strategy, sample size, stat analysis)

- Provide input to study set up (CRF review, randomization, DMP plan including specification for subset, important protocol deviation)

- Develop SAP/AAR (involving sensitivity analysis to support robustness of result) and coordinate review 

- Review the TFL, to coordinate review with the stat analyst, to approve the TFL

- Do the QC of the statistical analysis methodology

- Validate study specific dataset & analysis program specification 

- Approve deviation from TFL format 

- Propose SAR conclusion

- Prepare answer to study specific stat question (e.g. inspection, RA question)


Key Requirements:

- PhD, MS or Diploma in Statistics, Mathematics or Epidemiology or equivalent Area.

- Experience in SAS software and sample size computation for standard designs

- Good oral and written communication in English including ability to explain difficult issues and situations clearly and ensures meaning is understood

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