Senior Statistical Programmer Analyst
Roche - South San Francisco, CA

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Position Purpose: The Statistical Programmer Analyst has responsibility for statistical programming support for the Pharma Development, gRED, pRED, and/or EpiPRO organizations. He/she 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. Major Responsibilities and Accountabilities: - Prepares summarized information for clinical study team members - Lead statistical programming activities at study level or part of clinical project - Assess and clarify requirements, contribute to developing programming specifications, providing statistical programming solutions and ensure their efficient implementations - Determines and develops approaches to meet the project requirements - Responsible for accuracy and reliability of results. Builds and monitors quality in every aspect of job activities. - Has an familiarity with the types of risks associated with a study and the impact on the quality of deliverables. Implements the risk based quality control accordingly - Provides technical solutions to a wide range of problems. Independently determines and develops approach to solutions - Builds and maintains effective working relationships with cross-functional teams. Builds mutual purpose with team members - Considers strategies that will enable a smooth transition of a study or other task, if changes were to occur (e.g. with ‘fluid resourcing’ changes). Negotiates alternative timelines based on resourcing / priority constraints. Negotiate effectively with customers for reasonable timelines and scope - Contribute to user aspects of technical infrastructure or business process initiatives with a focus on statistical programming, data process and analysis reporting procedures. - Adapts to changing circumstances, policies, work assignments, and/or team members. Technical Requirements BA, BS or advanced degree in mathematics, statistics, biological sciences, computer science or equivalent experience. At least 3 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, Procedures, SAS macros, advanced data step and basic 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 data collection and database concepts including data flows in clinical trials, and Pharma industry data standards, such as CDISC/SDTM and ADaM data models. - Basic knowledge of FDA/ICH guidelines. Experience dealing with FDA/Regulatory requests. - Proficient at problem solving. Able to debug and resolve issues related to other peoples code and/or system macro code. - Understands the major biostatistical deliverables (Analysis Plan, CSR), and the requirement 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 clinical study team and SPA department - Ability to work on multiple tasks and meets timelines. Demonstrates ability to prioritize and project manage to optimize support. - Awareness and familiarity with the types of risks associated with a study and the impact on the quality of deliverables - Embraces and endorses change; Ability to see the big picture and understand what changes affect other departments work. - Shows willingness and ability to provide presentations with clear slides to a large group such as Coder's Corner, project meetings, SPA department. Able to provide a compelling position, supported by facts/evidence, which would lead to a solution that is of benefit to all parties involved.
Roche - 22 months ago - save job - copy to clipboard
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Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...