CONTRACT: Biostatistician
12 Months
Cologne, Germany
75 - 90 EURO P/H
My client, a global pharmaceutical is looking to take on board 2 x statisticians to join their team on one of the most stable and financially rewarding contracts on the market today.
Your Major Accountabilities:
*Acts as a Clinical Trial Biostatistician for several clinical trials within a clinical project or across multiple clinical projects.
*Works very closely with the other biostatisticians and the Clinical Program Biostatistician assigned to the project.
*Participates in the protocol development. Gives input into the trial design, efficacy and safety parameters and the planned statistical analyses. Performs the sample size calculations.
*Responds to the request for the randomization schedule and serves as randomization specialist when randomization schedule is generated internally. Have appropriate interactions with the IVRS vendor.
*Reviews the CRF and other data management related documents. Evaluates the quality of the database.
*Writes the Statistical Analysis Plan.
*Coordinates with other biostatisticians and statistical programmers to prepare the statistical analyses.
*Conducts the Data Review Meeting prior to breaking the blind in order to ensure accuracy.
*Presents Top-line clinical trial results. Gives input into the executive summary report.
*Reviews TFLs prior to release to the other project team members.
*Reviews the clinical trial report and provides input on the interpretation of results.
*Adheres to the company SOPs and working procedures.
*Communicates and coordinates all statistical activities with CRO statisticians.
*Ensures implementation of the project and Biostatistics department standards.
*Attends trial team meetings and collaborates with the clinical trial team to meet the timelines.
*Guide and support the biostatistician(s) assigned to support the clinical trials. Acts as a resource for junior biostatisticians on the team.
*Understands the regulatory requirements with respect to design and analysis of trials.
*Assists the Clinical Program Biostatistician with the statistical deliverables for regulatory submissions.
*Contribute and review publication document related to the responsible trials.
*Senior Biostatistician with sufficient experience may act as Clinical Program Biostatistician as agreed by the Head of Global Biostatistics Group
*Such other responsibilities and projects that the Company may assign.
Your Specific Skills:
*Experience in clinical trials, preferably Phase II - III.
*Sound knowledge of the ICH guidelines. Understanding of the regulatory requirements from EU and US health authorities and of the submission process.
*Good knowledge of statistical methodology.
*Experience with sample size software.
*Good knowledge in clinical trial related SAS programming.
*Good written and verbal communication skills in English.
*Able to work under pressure.
*Able to explain statistics in a non-technical manner to non-statisticians.
*Able to travel both, domestically and internationally, as business necessitates.
*Able to adapt to change.
Problem Solving:
*Proactively interacts with the Clinical Program Biostatistician and other clinical trial team members.
*Able to communicate clear, precise, accurate instructions.
*Able to propose and defend alternative trial designs and statistical analyses.
*Is a keen learner. Shows an active participation toward learning new statistical concepts, and the relevant aspects of the disease area of the related projects.
*Able to work in a multicultural global environment.
*Able to adapt to changing priorities and deliver results in a timely manner.
Your Experience:
3+ (with Ph.D.) to 6+ (with Master degree) years pharmaceutical industry experience with proven successful track record in pharmaceutical development.
For a confidential consultation call Russell Gillam on 0044 (0) 207 255 6665 or email your CV to russell.gillam@secpharma.com
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