An international contract research organisation (CRO) is looking to recruit a Senior Biostatistician to their office in Shanghai. The organisation is known for providing expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. This role offers an exciting opportunity to bring expertise and skill to a job with a company that makes a difference in the development of the pharmaceutical industry.
- Collaborates in the process of protocol development by choosing an appropriate study design, including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol. Sample size calculations may require some literature search to ensure that the study assumptions are correct.
- Writes and reviews Statistical Analysis Plans (SAPs) based on the protocol, including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor.
- Directs the activities of other Biostatistics personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other statisticians in the department.
- Participates in project teams as Biostatistics representative, interfacing as necessary with other departmental project team representatives globally.
- Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
- Participates in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting statistician.
- Conducts and participates in review and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP.
- Discusses time estimates for completion of study related activities with the internal stakeholders globally.
- Ensures proper study closeout by documenting and archiving study related materials according to Standard Operating Procedures (SOPs), and/or sponsor instructions.
- Generates and/or reviews randomization schedule(s) to ensure there are no errors present and sponsor and protocol requirements are met. Performs ongoing monitoring of actual randomization scheme applied by IVRS/IWRS.
Skills and Requirements:
- MS or PhD in Biostatistics or related field.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Lunah Wang at firstname.lastname@example.org or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.