1. Position Title: (Senior) Statistician in Pharmacometrics/Clinical Statistics
Subgroup / SC: Bayer Schering Pharma AG Location: Beijing
Business Unit / Division: Global Clinical Development Function / Department: Global Biostatistics
2. Position purpose (A brief statement indicating the basic purpose of the position)
• Serve as the Study Statistician for a Study Team, ensuring the use of appropriate and efficient methods of statistical analysis to support the development and submission of Bayer Schering Pharma products according to global and regional standards, procedures and regulatory guidelines
3. Major tasks and responsibilities of position (max. 8 key topics)
• Serve as the Study Statistician and as the expert on the Study Team for statistical aspects including those related to scientific and regulatory issues
• Create statistical methodology section, including sample size calculation, for study protocol
• Work closely with Statistical Programmers to ensure creation of analysis data sets, statistical summary tables, listings, figures and statistical report
• Perform inferential analyses, including documentation, to support decision-making and regulatory submissions, publications and scientific presentations
• Interpret results in collaboration with Clinical Pharmacologists, Clinicians, and Medical Writers
• Contribute to and review medical research report
• Ensure accurate and timely delivery of statistical work outsourced to a CRO for the study
4. Value added to the success of the company – what are the main objectives of the function?
Contribution to
• drug research,
• the development of new drugs,
• the approval of new drugs by health authorities, and
• the surveillance of marketed drugs
according to the major tasks and responsibilities of the position (cf. sec. 3).
5. Contribution context: Multiple choice of a pick list + free text with limited characters
0 Individual Contributor others:
1 Team Member
0 Team Leader
0 Supervisor
0 Manage Supervisors
0 Manage Function / Department
6. Work relations
(List the most important work relationships with internal and external partners/customers)
