Statistical Programmer (SPA-2)
The Statistical Programmer has responsibility for statistical programming support for the Pharma Development, gRED, pRED, and/or EpiPRO organizations. He/she supports statistical programming teams on assigned study level activities in planning, designing, and implementing statistical software solutions for the reporting and analysis of clinical trials in accordance with applicable processes.
Major Responsibilities and Accountabilities: Contributes to SPA team in preparing summarized information to clinical study team members Assist statistical programming activities at study level or components of a clinical project as applicable Able to access and clarify requirements, provide statistical programming solutions and ensure their efficient implementations under supervision Under guidance of a senior SPA, develops approaches to meet the study and project requirements Assist in determining and developing approach to technical solutions Responsible for accuracy and reliability of results. Builds and monitors quality in every aspect of job activities. Has an awareness and familiarity with the types of risks associated with a study and the impact on the quality of deliverables Is aware of timelines and scope based on resourcing / priority constraints within the SPA team and understand their implications on individual work assignments Builds and maintains effective working relationships with SPA team members. Adapts to changing circumstances, policies, work assignments, and/or team members. Able to multi-task and prioritize between tasks Technical Requirements
BA, BS or advanced degree in mathematics, statistics, biological sciences, computer science or equivalent experience. At least 1 years SAS programming experience in clinical research preferably with emphasis in the development and support of the analysis of clinical trial data.
Experience and/or Competencies Required:
Experience of SAS/BASE and Procedures; Basic knowledge of SAS statistical procedures Knowledge of statistical concepts, Has knowledge of analysis of continuous and categorical data. Familiar with relevant operating systems (e.g. UNIX), Has basic understanding data collection and database concepts including data flows in clinical trials Basic knowledge of FDA/ICH guidelines and Pharma industry data standards, such as CDISC/SDTM, ADaM data models. Capable of problem solving. Able to debug and resolve issues related to other peoples code and/or system macro code independently Understands the major biostatistical deliverables (Analysis Plan, CSR), and the requirements 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). Capable of clear and timely written / verbal communication and effective listening/understanding with SPA team members Ability to work on multiple tasks and meets timelines. Demonstrates ability to prioritize and apply project management skills to optimize support Embraces and endorses change; Shows willingness and ability to provide short presentations with clear slides to a small group.
Roche - 21 months ago
Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...