Biotech/Pharmaceutical

Statistical Programming Project Leader

Permanent

Penfield Search Partners

Contact: Linda Aronova –  laronova@penfieldsearch.com

Job Description: Lead one or more statistical programming project team(s) in the Rare Diseases and Rare Blood Disorder projects. Responsible for all programming activities at the project/indication level. In addition, contribute to the therapeutic area and department initiatives and task forces for innovation and process improvements.

Major Responsibilities:

  • Provide leadership, guidance, and hands-on support to ensure high quality and timely statistical programming deliverables within a project, ensure technical validity, compliance to internal standards and SOPs, regulatory requirements
  • Plan and execute statistical programming project activities, timelines, and resource use in cross-site global setting; provide justification for planned resource needs, seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas, with minimal direction from group head.
  • Ensure standardization and consistency in specifications and programming deliverables across individual studies and for integrated analyses
  • Provide technical guidance and leadership to metadata specifications and project/study specific data requirements
  • Lead regulatory submission activities, including electronic submission packages
  • Supervise the quality controls (QC) methods and processes for programming deliverables in both study and submission level activities
  • Provide guidance and mentor junior staff on programming techniques, project management and implementation of standards
  • Collaborate effectively with project statistician and with other functions in the aligned project team; participate in clinical project meetings and provide inputs, whenever relevant
  • Lead oversight activities for outsourcing engagements; guide team members to effectively interact with external resources
  • Participate in departmental initiatives; provide inputs to programming standardization and process optimization

Required Education/Experience:

  • Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.
  • MS / BS with at least 5+ / 7+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry
  • Excellent technical skills in statistical programming, with advanced knowledge in SAS and other statistical computing software (R, R-Shiny)
  • Ability to perform, coordinate and oversee the preparation, execution, reporting and documentation of all programming deliverables of a project, with minimal supervision
  • Knowledge on regulatory requirement evolution (SDTM, SDRG, ADRG, ADAM, XML format, etc.); thorough understanding of pharmaceutical clinical development (i.e., statistical concepts, techniques, and clinical trial principles) and ability to lead regulatory submissions
  • Ability to collaborate with external partners (CROs, Partners, etc.) and manage outsourced activities
  • Excellent verbal and written communication skills in an English global environment; ability to have efficient exchanges with partners, service providers, and colleagues across geographical locations
  • Strong skills that demonstrate initiative, motivation, and teamwork in global interdisciplinary teams
  • Ability and mindset to embrace change, innovate and continuously improve programming practice

Tagged as: Statistical Programming Project Leader