Manager, Statistical Programmer

Biometrics Bothell, Washington South San Francisco, California


Description

Position Summary

Design, develop, and modify SAS programs to analyze and evaluate clinical data in accordance with statistical analysis plans.  Assumes a leadership role on an entire study, project, or integration.  Interact with cross-functional study, project, and filing teams to proactively and independently determine programming tasks, timelines, assignments, and resource requirements and oversee programming efforts to ensure the timely delivery of high-quality output according to company and industry standards.  Represent statistical programming in the review of key study and project documents and data set or reporting specifications. Recognize inconsistencies and initiate resolution of data problems when necessary. Assist programming management with or be the lead on cross-functional process improvement initiatives and resource allocation.  Entry position to begin functioning as a line manager for one or more salaried programmers while also overseeing activities performed by contract and remote FSP programmers.


Principal Responsibilities

  • Ensure accuracy, completeness, quality, and timely delivery of statistical programming deliverables at the study, filing, project, or small product level
  • Independently implement complex analysis algorithms for assigned projects or studies
  • Provide technical leadership to study and project team programmers including programming techniques.  Decide on extent of implementation of departmental and product-level standards, tools, and processes in assigned studies and projects with advice from the lead programmer
  • Contribute to product-level specifications based on analysis need and ensure compliance with company and industry standards
  • Review and provide feedback on deliverables from other clinical groups including but not limited to statistical analysis plans; table, listing, and figure shells; data management plans; data transfer plans; and case report forms
  • Clear and proactive communication with study and project teams to clarify requirements and specifications, update others on assignment status, and convey data irregularities
  • Initiate, lead, and participate in planned departmental and cross-functional initiatives that facilitate standards, infrastructure, and process enhancements
  • Manage resources efficiently across assigned projects to maximize synergies
  • Provide oversight, guidance, mentoring, feedback, and performance reviews to direct reports
  • Participate in interviews and, as a hiring manager, decide which candidates to hire. Train and mentor new and junior programmers
  • Assist programming management on resource allocation

 

Qualifications

  • 8+ years (BS) or 6+ (MS/PhD) of SAS programming experience in the Biotechnology, Pharmaceutical, Medical Device, and Health Care industries
  • 5+ years of experience in performing statistical programming using SAS® for creating and testing analysis datasets, tables, listings and figures for Phase I-IV clinical trials
  • 3+ years of experience in managing statistical programming projects, preferentially (but not necessarily) with direct line management responsibilities for internal salaried staff
  • 2+ years of experience in writing SAS macros
  • Demonstrated proactivity and strong attention to detail
  • Expert knowledge and understanding of SAS® programming concepts and skills.
  • Experience in oncology studies; experience with integrations and e-submissions a strong plus
  • Good understanding of and hands-on experience with CDISC SDTM and ADaM standards

Education

  • BS, MS, or PhD

 

Competencies

  • Learning, problem solving, and situational adaptability
  • Plan and optimize work processes of self and across multiple programming teams
  • Communicate and work effectively both independently and in a team environment
  • Focused on results
  • Make high-quality decisions at the study or project level
  • Proven mentoring and instructional skills to allow growing into a managerial role