Director, Statistics

Key Responsibilities:

• Strategic Leadership in Advanced Statistics:
  • Provide expert statistical guidance for late-phase clinical trials and real-world evidence (RWE) studies across programs including Nephrology, CNS and Rare Disease.
  • Lead statistical contributions to HTAs and Market Access submissions, ensuring that all statistical methodologies meet the necessary regulatory and reimbursement requirements.
  • Contribute to the development and implementation of HTA-related statistical methodologies, such as matching-adjusted indirect comparison (MAIC), Bayesian network meta-analysis and clinical/regional input for health economic models.
  • Ensure that analyses supporting "Consistent with FDA Label" (CFL) claims are scientifically appropriate and statistically sound (SASS). Lead or serve as the key point of contact on various statistics related initiatives.

• Cross-functional Collaboration:
  • Work closely with Global Value Evidence, Medical Affairs, Market Access, Regulatory, Clinical Management and Global Clinical Development teams to ensure alignment and successful execution of evidence generation strategies.
  • Provide statistical leadership in preparing evidence for HTA submissions and pricing/reimbursement strategies.
  • Collaborate with external vendors and partners to ensure the timely, high-quality delivery of statistical analyses and reports.

• Evidence Generation and Statistical Support:
  • Lead the development and execution of statistical analysis plans (SAPs) and ensure the integrity and robustness of statistical analyses for clinical trials and real-world studies.
  • Lead the adoption of Bayesian frameworks to maximize data efficiency, specifically designing mechanisms to borrow information from historical trials or external control arms to support study designs and evidence generation.
  • Ensure consistency in statistical methods and analyses across therapeutic areas, particularly for Nephrology, CNS and Rare Disease.

• Innovative Methodologies and Statistical Tools:
  • Champion the application of machine learning (ML) and predictive modeling techniques to drive population enrichment strategies, identifying high-response patient subgroups to optimize late-phase and real-world study designs.
  • Facilitate Bayesian AI generative models for synthetic control arms and machine learning post-hoc analyses of clinical trials and real-world data (RWD).
  • Stay abreast of the latest developments in HTA, IEP, and statistical methodologies to ensure best practices and efficient approaches.

• Training and Mentorship:
  • Provide mentorship and leadership to junior statisticians and other team members.
  • Contribute to the creation and maintenance of departmental SOPs and work instructions related to statistical methodologies.
  • Support training and knowledge-sharing within the organization on statistical methods, particularly in the context of HTA, market access, and real-world evidence.

• Vendor and External Collaboration:
  • Oversee the selection and management of external vendors, ensuring their work aligns with the organization’s standards and timelines.
  • Act as the primary statistical liaison in vendor collaborations, providing guidance and oversight to ensure that external analyses meet required standards.

Qualifications

• PhD in Biostatistics, Statistics, or a related field.
• 8+ years of experience in biostatistics, including substantial expertise in HTA, and supporting statistical and advanced analytics for Market Access, HEOR, and RWE.
• Deep familiarity with current HTA/regulatory frameworks (Bayesian, CFL, External Control, Covariates adjustment, Patient-Focused Drug Development, Enrichment, AI).
• In-depth experience with indirect treatment comparisons such as MAIC, NMA, and clinical/regional input for health economic models
• Proven experience in late-phase clinical trials and real-world studies in multiple therapeutic areas (Nephrology/CNS/Rare Disease is a plus but not required).
• Knowledge of health economics, pricing and reimbursement, and HTA processes/guidance for global market access.
• Strong expertise in statistical software packages, including R and SAS.
• Excellent communication skills in communication complex ideas, challenges, and solutions to the leadership.
• Proven ability to communicate complex statistical concepts effectively to both technical and non-technical stakeholders.
• Leadership in effectively managing internal and/or vendor teams to deliver high quality results
• Leadership and mentoring experience, with the ability to work collaboratively in a cross-functional environment.