Job Description
Responsibilities
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
Technical:
Perform consistency review of clinical trial documents including protocols, SAPs, CRFs, CSRs
Author and review simple and complex study TFL shells
Author and review simple and complex dataset standards
Perform data checks and data exploration (e.g. using frequencies, histograms)
Program and QC routine and ad hoc datasets and TFLs (in SAS & R) following specifications, applying good programming practice
Complete and review CDISC Validation tool reports
Ensure the appropriate standards are being applied and adhered to
Familiarisation with simple statistical techniques (e.g. t-test, ANOVA, regression, standard survival)
Review of project management related documents
Maintain study master file documents and any other documents that are required to be audit ready
Has worked on R and R shiny dashboards.
Project Management:
Act as Lead Programmer and/or Veramed Project Manager for client projects and studies
Maintain the project plan
Proactive management of resource, scope change and risks
Manage the delivery of projects to budget
Manage client expectations and issue resolution
General:
Lead internal and client study team meetings effectively
Present study updates internally and at client meetings
Share scientific, technical and practical knowledge within the team and with colleagues
Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
Build effective collaborative working relationships with internal and client team members
Seek opportunities to develop innovative ideas, sharing when appropriate
Line management or mentorship of more junior team members
Contribution to development of internal training materials
Contribution to internal process improvement initiatives
Minimum Qualification Requirements
BSc, MSc or PhD in numerical discipline (or relevant equivalent industry experience)
At least 4 years of relevant industry experience
Other Information/Additional Requirements
Understanding of clinical drug development process, relevant disease areas, endpoints and study designs
Awareness of industry and project standards & ICH guidelines
Excellent verbal and written communication skills
Interpersonal/teamwork skills for effective interactions
Proficiency in data handling using SAS & R
Self-management skills with a focus on results for timely and accurate completion of competing deliverables
Demonstrated problem solving ability and attention to detail
Ability to work independently and as part of a team
Are you interested in this position?
Apply by clicking on the “Apply Now” button below!
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