Director Biostatistics Lead RWE

We have a current opportunity for a Director Biostatistics Lead RWE on a permanent basis. The position will be based in Boston, MA or can be remote. For further information about this position please apply.

The Director of Biostatistics RWE (Real-World Evidence) will lead the biostatistics team in designing, analyzing, and interpreting real-world data to generate evidence that supports clinical and regulatory decision-making. This role involves strategic planning, methodological development, and collaboration with cross-functional teams to leverage real-world data for improving patient outcomes and healthcare delivery. The Director will ensure the scientific integrity and quality of biostatistical analyses and contribute to the development of RWE strategies that demonstrate the value of healthcare interventions.

Base Salary: $210-250,000 base + additional benefits

Key Responsibilities

• Leadership and Management:

  • Lead and mentor a team of RWE statisticians, providing guidance and fostering professional development.
  • Oversee the planning, execution, and reporting of biostatistical analyses for RWE studies.
  • Ensure adherence to regulatory requirements and industry standards in all biostatistical activities.

• Strategic Planning:

  • Develop and implement biostatistical strategies to support RWE objectives.
  • Collaborate with clinical, medical affairs, and market access teams to align biostatistical methodologies with overall research goals.
  • Identify and address methodological challenges in RWE studies.

• Study Design and Analysis:

  • Design robust and innovative statistical approaches for real-world evidence generation.
  • Perform and oversee statistical analyses, including survival analysis, regression modeling, and propensity score matching.
  • Interpret and communicate statistical findings to internal and external stakeholders.

• Collaboration and Communication:

  • Work closely with cross-functional teams, including clinical development, medical affairs, and market access, to integrate biostatistical insights into broader research initiatives.
  • Present biostatistical results at scientific conferences, regulatory meetings, and to key opinion leaders.
  • Prepare and review manuscripts, reports, and presentations for publication and dissemination.

• Quality Assurance and Compliance:

  • Ensure the accuracy, reliability, and validity of biostatistical analyses.
  • Maintain compliance with regulatory guidelines and best practices in biostatistics.
  • Implement quality control procedures and continuous improvement initiatives.

Qualifications

• Education:

  • PhD or Master's degree in Biostatistics, Statistics, Epidemiology, or a related field.

• Experience:

  • Minimum of 8 years of experience in biostatistics, with a focus on real-world evidence.
  • Proven track record of leading biostatistical teams and managing complex projects.
  • Strong experience with stat methodology, real world data, and observational studies
  • Experience in the pharmaceutical, biotechnology, or healthcare industry preferred.

• Skills:

  • Expertise in statistical software (e.g., SAS, R, STATA).
  • Strong analytical and problem-solving skills.
  • Excellent communication and presentation skills.
  • Ability to work collaboratively in a multidisciplinary environment.