Biotech/Pharmaceutical

Principal Statistical Programmer

Permanent

Penfield Search Partners

Contact: Linda Aronova 646.882.9021 laronova@penfieldsearch.com

Job Description:

  • Provide advanced data science expertise to cross-functional projects and drive delivery of data science solutions that drive value to company
  • Apply a range of data science methodologies, developing novel data science solutions where off-the-shelf methodologies do not fit
  • Translate unstructured, complex business problems into the appropriate data problem, model and analytical solutions
  • Generate complex ad-hoc analyses combining disparate concepts or creating new approaches.
  • Design and create new analytic procedures & automation
  • Developing, maintaining and applying ongoing knowledge and awareness in trends, standard methodology and new developments in analytics and data science
  • Works with Biometrics team members to develop data visualization tools and techniques in translating clinical analytics needs into data visualization and semantic data access requirements
  • Develops and performs quality control on analysis datasets and tables, figures and listings via an appropriate statistical analysis system (i.e. SAS).
  • Provides input to the statistical analysis plan, table shells, data integration plans, and publications.
  • Helps ensure the accuracy and consistency of data flow from case report forms (CRFs) and database definitions, through to and specifications for analysis
  • Programs statistical analyses (via analysis datasets, tables, figures, listings, etc.) using an appropriate statistical analysis system (i.e. SAS).
  • Performs quality review of analysis dataset and TFL programs developed by other programmers and biostatisticians.
  • Verifies that all statistical analysis system programs and associated documentation are archived following the creation of final
  • Assists in the development of new processes and makes sure all process improvements are implemented.
  • Reviews and provides feedback regarding statistical analyses
  • Collaborates with other team members to develop quality reports, publications, and regulatory submissions.
  • Helps maintain libraries of documented and validated programs, macros, and procedures which can be reused to aid in department.
  • Review and support key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan, eCRF) to ensure alignment with programming objectives and requirements.
  • Carry out programming in accordance with project standards, programming conventions, programming specifications and file transfers.
  • Aggregate datasets from disparate sources and file types and formats within and across studies (for example specialty labs in excel, CSV format with SAS datasets from the EDC) into one cohesive dataset that is ready for use by SAS programmers and statisticians.
  • Develop milestones and timelines, relay these objectives to the team, and ensure that the team is successful in obtaining these goals.

Qualifications & Experience:

  • Bachelors or Masters degree in computer science, Data Sciences, Informatics, Statistics and/or Biostatistics required.
  • 5-8 years programming experience in pharmaceutical or CRO.
  • Proficiency in SAS (Statistical Analysis Software): i.e. Base, Stat, Graph components, with general computing knowledge related to clinical development activities preferred.
  • Proficiency in at least one of the languages: Python, Java, R, Perl and C++.
  • Strong Knowledge of Oncology
  • Excellent analytical & troubleshooting skills.
  • Experience in data visualization and data sciences.
  • Ability to provide quality output and deliverables, in adherence with challenging timelines.
  • Proven track record of being able to work on multiple studies.
  • Desirable
  • Experience supporting programming for regulatory filings (e.g. NDA, BLA, MAA)*.
  • Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements.
  • Project management skills.

Tagged as: Principal Statistical Programmer

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