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Head of Statistical Programming

2 months ago

Waltham, Massachusetts, United States Muraloncology Full time

Position Overview: The Director of Statistical Programming at Muraloncology will spearhead programming initiatives for clinical trials, ensuring alignment with study specifications and deadlines. This role demands collaboration with internal statistical and clinical programming teams, statisticians, cross-functional departments, and external service providers to guarantee timely and high-caliber programming outputs that adhere to regulatory guidelines.

Key Responsibilities:

  • Oversee and direct programming tasks to maintain compliance with timelines, quality benchmarks, data integrity, and regulatory standards.
  • Provide direct programming assistance for clinical studies, encompassing study reports, ad hoc analyses, exploratory data evaluations, conference presentations, publications, safety reviews, and regulatory submissions.
  • Supervise the programming contributions from external service providers to ensure precision, uniformity, and adherence to regulatory standards.
  • Collaborate effectively with cross-functional teams (including clinical, biostatistics, and data management) to formulate programming strategies, including specifications, analysis datasets, and outputs.
  • Assist in the creation and review of study-related documentation, such as protocols, statistical analysis plans, case report forms, and data transfer specifications.
  • Convey programming strategies, challenges, and project progress to key stakeholders, including senior management.
  • Establish and uphold programming standards, processes, and best practices to ensure consistency and quality across all programming deliverables.
  • Develop or assess software tools and procedures to enhance programming efficiency, quality, and interdepartmental collaboration.

Qualifications:

  • A Bachelor's degree or higher in statistics, biostatistics, or a related discipline.
  • Over 10 years of experience in statistical programming within the pharmaceutical or biotechnology sectors, particularly in clinical trial data analysis and reporting.
  • Experience in oncology is highly desirable.
  • Proficient in statistical programming languages, such as SAS or R.
  • Comprehensive understanding of CDISC SDTM and ADaM Implementation Guidelines.
  • Ability to work autonomously and lead programming teams effectively.
  • Experience in managing relationships with CROs and external service providers.
  • Excellent communication and collaboration skills, capable of working effectively with cross-functional teams and external partners.
  • Familiarity with regulatory submissions and integrated analyses.
  • Proven ability to thrive in a fast-paced, dynamic environment, with adaptability to shifting priorities and timelines.