We are seeking a senior biostatistician to work as a consultant onsite with a pharmaceutical company in Copenhagen.
The contract is initially for 6 months but due to the nature of the project there is a good chance to be extended for up to 2 years. The rate would be in the region of £70 p/h (or equivalent in local currency)
Ideally we are looking for someone who has at least an MSc and a minimum of 5 years experience working with clinical trial data. We are flexible on phase and therapy area.
Tasks to include
Providing statistical input into protocol and case report form (CRF) development in all therapeutic areas (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, edit checks for clinical trial data);
communicating with clients regarding study protocol or statistical analysis issues;
writing detailed statistical analysis plans including specifications for analysis files, consistency checks, tables, and figures.
Additionally, you will analyze clinical trial data producing accurate results representing the outcome of the trial, validate statistical output, accurately interpret and clearly communicate statistical results and concepts to non-statisticians.
With the medical writer, you will co-author final integrated reports of clinical trial data by writing thorough and clear statistical methods sections and producing the statistical appendix for the final report.
You also will provide statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.
In this role you will provide input into statistical standard operating procedures (SOPs) and general standardization efforts (e.g., statistical methodology standards, standard data presentations) and participate in interactions with regulatory agencies, as required.
You will be expected to collaborate effectively with members (internal and external) of clinical trial implementation teams and with Biometrics colleagues, and keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
If you would be interested to have more details please contact me on [log in to unmask]
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