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Instat's biostatisticians and statistical programmers have successfully served in the following types of engagements:
- Clinical study design and planning, sample size calculations, and protocol input.
- Project biostatistician and programming support for full clinical study analysis, both interim and final
- Unblinded biostatistician for DSMB or IDMC meetings, presenting informative slides with figures to monitor safety and efficacy.
- Interim analysis with early-stopping boundaries (O'Brien-Flemming, Pocock) and conditional power calculations presented to recommend appropriate decisions.
- Advisory role in preparing for regulator submissions and response to reviewer/rapporteur questions. Advise and support for advisory committee meetings (ODAC for example).
- Randomization services.
- Co-author on publications, providing statistical results and reviewing publications.
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Experience