Statistical Programming Manager/ Sr. Manager 部门:Clinical and Medical  工作类型:Full time, Employee
工作地点:Shanghai, China
立即申请
职位申请

Overview:

The Statistical Programmer Analyst leads statistical programming activities and via external partners provides end to end statistical programming support in planning, specifying, designing, developing and implementing statistical software solutions for the reporting and analysis of clinical trials in accordance with applicable processes.


Responsibilities:


  • Work with external partners to prepares and distributes summarized statistical analysis results to clinical study team members
  • Responsible for accuracy and reliability of results. Builds and monitors quality in every aspect of job activities.
  • Recommends technical and process solutions that can be used or developed to increase efficiency of project work.
  • Provides technical solutions to a wider range of problems with higher level of complexity.
  • Independently determines and develops approach to solutions. Adapts to changing circumstances,policies, work assignments, and/or team members.
  • Considers strategies that will allow consistency or continuity of subsequent tasks (e.g., multiple studies in an ISE or ISS).
  • Contributes to the development of department-level standards, tools and templates.
  • Determines technical objectives and direction for project(s). Develop timelines for statistical programming analysis component of the study
  • Prioritizes and delegates tasks based on the importance of the deliverable and awareness of overall timelines in order to efficiently produce high quality deliverables.
  • Proactively addresses project uncertainties to minimize risk and alerts or escalates the issue to the appropriate person (project team member, Lead programmer, or management). Identifies, communicates and overcomes technical and interpersonal obstacles.
  • Negotiates effectively within project teams and working groups for reasonable timelines and scope, also negotiates alternative timelines based on resourcing / priority constraints.
  • Leads statistical programming activities of a set of studies or indication.
  • Contributes to user aspects of technical infrastructure or business process initiatives with a focus on statistical programming.


Education/Qualification:


  • BA, BS or advanced degree in mathematics, statistics, biological sciences, computer science or equivalent experience.
  • At least 2-3 years SAS programming experience. Experience in R programming and other data visualization tools in preferred.
  • Knowledge in clinical research with emphasis in the development and support of the analysis of clinical trial data.


Qualification/Abilities:


  • Advanced knowledge of SAS programming techniques, such as complex SAS macros, advanced SAS/GRAPH; Knowledge of SAS statistical procedures
  • Knowledge of statistical concepts, such as p-values, rates and proportion, frequencies, confidence intervals, survival analysis, non-parametric analysis. Capable of implementing these ideas in clear, efficient SAS codes for the purpose of data analysis and reporting
  • Familiar with relevant operating systems (e.g. UNIX); Has good understanding of data collection and database concepts including data flows in clinical trials, and Pharma industry data standards, such as CDISC/SDTM and ADaM data models.
  • Knowledge of ICH guidelines. Experience supporting regulatory submissions in China and dealing with requests from Health Authorities.
  • Proficient at problem solving. Able to debug and resolve issues related to other people’s code and/or system macro code.
  • Understands the major biostatistical deliverables (Analysis Plan, CSR), and the process of developing publications for external consumption (abstracts, posters, slide decks, manuscripts).
  • Understands the overall design of a clinical study, and its statistical and clinical rationale (e.g., dose escalation for MTD, comparison to standard of care).
  • Able to communicate clearly and without ambiguity in speaking and in writing.
  • Embraces and endorses change; Ability to see the big picture and understand what changes affect other departments work.