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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 objectives and deadlines. This role requires collaboration with internal statistical and clinical programming teams, statisticians, and external service providers to guarantee timely and high-quality programming deliverables that meet regulatory standards.

Key Responsibilities:

  • Oversee and direct programming operations to maintain compliance with timelines, quality benchmarks, and regulatory guidelines.
  • Provide direct programming assistance for clinical studies, including the preparation of study reports, conducting ad hoc analyses, and supporting regulatory submissions.
  • Supervise the programming contributions from external service providers to ensure precision, uniformity, and adherence to regulatory requirements.
  • Work collaboratively with cross-functional teams (e.g., clinical, biostatistics, data management) to formulate programming strategies, including the creation of specifications and analysis datasets.
  • Assist in the development and evaluation of study-related documentation, such as protocols, statistical analysis plans, and data collection frameworks.
  • Effectively communicate programming strategies, challenges, and project progress to stakeholders, including senior leadership.
  • Establish and uphold programming standards and best practices to ensure quality and consistency across all programming outputs.
  • Develop or assess software tools and methodologies to enhance programming efficiency and interdepartmental collaboration.

Qualifications:

  • A Bachelor’s degree or higher in statistics, biostatistics, or a related discipline.
  • A minimum of 10 years of experience in statistical programming within the pharmaceutical or biotechnology sectors, with a focus on clinical trial data analysis.
  • Experience in oncology is preferred.
  • Proficient in statistical programming languages, particularly SAS or R.
  • Comprehensive understanding of CDISC SDTM and ADaM Implementation Guidelines.
  • Ability to work autonomously as well as lead programming teams effectively.
  • Experience in managing relationships with CROs and FSPs.
  • Excellent communication and teamwork skills, with a proven ability to collaborate with diverse teams and external partners.
  • Familiarity with regulatory submissions and integrated analyses.
  • Proven ability to thrive in a fast-paced environment, adapting to shifting priorities and timelines.