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GERMAN NOT NEEDED!
The Senior Statistician is responsible for maintaining and constantly improving The firm’s
performance and quality in biostatistical services. This includes but is not limited to statistical support services for internal and external customers, planning and programming statistical analysis and quality control. Responsibilities also include supporting employees with regard to SAS programming, project management activities and communication with customers as well as improvement of standard operating procedures.
This position will interface at senior levels with other departments to improve processes and efficiency throughout The firm.
Essential Job Functions
? Provide review and guidance to the team and customers on all statistical aspects of clinical trials.
? Project work and responsibility for the statistical input in developing of major documents, including statistical analysis plans, quality control plan for SAS programming and clinical study reports.
? Program and validate tables, figures, listings, statistical analysis and CDISC datasets for clinical trials and observational studies with SAS.
? Quality control tables, figures listings, statistical analysis and CDISC datasets for clinical trials and observational studies.
? Entire responsibility for project management activities of statistical and SAS programming
? Self-dependent oral and written communication with customers and a sound representation of the firm.
? Organizing and heading meetings with customers, e.g. SAP discussion meetings or Data Review Meetings.
? Maintain and enhance SAS macros.
? Work closely with supervisor in defining strategic approaches to meet operational requirements and to ensure a coordinated approach to biometrics work.
? Maintain and develop SOPs in order to improve quality, efficiency and timeliness of work
? Maintain comprehensive knowledge of theoretical and applied statistics and regulatory guidelines, and attend conferences.
? Additional duties as required.
? Minimum of a Masters Degree/Diploma in Statistics, Biostatistics, or a related field.
? Minimum of 7 years of experience in clinical trials related statistical analysis and study design.
? Experience working in the pharmaceutical industry or a CRO and comprehensive understanding of regulatory guidelines in drug research.
? Excellent computer skills and proficiency with SAS (V9), MS Word, Excel and the Internet.
? Experience in adaptive study designs, oncology clinical trials and CDISC data standards.
? Strong problem solving skills and ability to work both independently and in teams.
? Excellent communication skills – interpersonal and both verbal and written in English and German.
? Experience in project management.
? A flexible attitude with respect to work assignments and new learning.
? Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.