Biotech/Pharmaceutical

Statistical Programming Lead

Permanent

Penfield Search Partners

Contact: Linda Aronova – laronova@penfieldsearch.com

Primary Duties: Statistical Programming Lead provides functional expertise and leadership to clinical project teams to lead statistical programming and support the development, regulatory approval, and market acceptance of company Products. This position is primarily responsible for the design, development, and implementation of technical solutions for integrating, analyzing and reporting clinical data. This individual will use knowledge of CDISC SDTM and ADaM standards to support Biometrics in statistical analysis, including generating analysis data listing, tables, figures and create all files necessary to support an electronic submission in the eCTD format. Additionally, the successful candidate will use their strong people management and supervisory skills to provide direct line management to the statistical programmers.

Responsibilities:

  • Provides comprehensive programming leadership and support to complex clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices
  • Develop operational processes and standards for the statistical programming group including templates for SDTM, ADaM and TLFs specifications
  • Develop and validate technical programming specifications for analysis datasets, statistical tables, figures and listings
  • Evaluate CDISC electronic data packages for completeness and ensure submission readiness of study data packages per CDISC standards and FDA guidance
  • Implement state-of-the-art programming practices and quality guidelines in compliance with regulatory requirements
  • Collaborate with Data Management to implement the CDISC standard at the CRF and database build-up stage; review annotated case report forms
  • Effectively and persuasively presents statistical programming concepts, assessment of risks and their impacts and logical arguments to other statistical programmers, statisticians, scientists and non-scientists
  • Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures
  • Manages critical deadlines, demonstrates ability to resolve issues, and ensures studies will be completed within designated timeframe
  • Contributes to the Biometrics process establishment and SOPs development
  • Coordinate the development of SAS macros and tools for repeated program use for exploratory and post-hoc analyses
  • Recognize inconsistencies and initiate resolution of data problems
  • Manages statistical programming staff by appropriate assignment of responsibilities, defining scope and reviewing activities/progress so that projects are delivered on time with high quality
  • Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceed those goals

Education and Experience Requirements:

  • BS/MS in computer science, statistics or life sciences required
  • At least 12 years programming experience in the drug development industry including support of significant regulatory filings and minimum 5 years of experience in managing technical professionals in a regulated environment
  • Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data
  • Advanced Experiences with statistical programming using the SAS software including development and use of SAS Macros
  • Broad expertise in statistical programming and in developing computing strategies
  • In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases
  • Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g., MS office, XML, Pinnacle 21)
  • Key Skills, Abilities, and Competencies

Required skills for this position:

  • Previous experience supporting SAS macro and/or system utility development preferred
  • Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming preferred
  • Advanced working knowledge of CDISC SDTM and ADaM, and extensive experience of their implementation in clinical trials analysis preferred
  • Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials preferred
  • Knowledge of all phases of drug development, including early and late phase clinical development and submission preferred
  • Demonstrated ability to work in a team environment with clinical team members

Complexity and Problem Solving

  • Strong problem-solving skills with ability to process complex information, break it into logical steps/tasks to help solve, present it clearly to a range of audiences
  • Demonstrated ability and desire to navigate complex situations with various levels of uncertainty
  • Ability to see and understand a broader, enterprise level perspective and understand and assess impact to statistical programming

Tagged as: Statistical Programming Lead