Senior Director, Statistical Innovation

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer senior-level advisory expertise on therapeutic-area and product-development strategies, development programs, and clinical trials.

• Lead the assessment and selection of traditional and innovative study designs, estimands, and estimators.

• Counsel senior stakeholders on intricate statistical and methodological challenges impacting development decisions, regulatory interactions, and submissions.

• Integrate and interpret simulation outcomes, regulatory considerations, operational feasibility, and development goals.

• Deliver specifications to the Simulation and Modeling team and develop, review, and endorse simulation plans and results.

• Link insights and lessons learned across products and programs to foster a consistent approach to innovative design and analysis strategies.

• Advise Biostatistics TA leaders, GSLs, and EGTs regarding product strategy, program architecture, and clinical study design.

• Direct, apply, interpret, and communicate modeling and simulation in collaboration with quantitative partners.

• Evaluate study design alternatives, proposals, development plans, Phase 2 and Phase 3 protocols, and governance submissions.

• Establish strategic alliances with biostatistics leaders, strategic development, GSLs, EGT functional leaders, FSC members, and senior stakeholders.

• Advocate for innovative designs and analytical methods across products and programs.

• Approve the simulation plan.

• Generate design alternatives for ECP, develop simulation plans, design simulation tools, and create detailed study-specific designs.

⛳️ Requirements

• Doctorate degree with 5 years of experience in Statistics/Biostatistics or related fields with significant statistical content, OR Master’s degree with 9 years, OR Bachelor’s degree with 11 years.

• Minimum of 5 years of experience in managing personnel and/or leadership roles overseeing teams, projects, programs, or directing resource allocation.

• At least 12 years of post-graduate statistical experience within the biopharmaceutical sector in clinical trial design, execution, analysis, and reporting.

• Demonstrated statistical expertise and leadership throughout drug development phases, regulatory submissions, and payer interactions.

• Strategic statistical leadership at the product level for at least one complex program or multiple moderately complex programs.

• Mastery of statistical principles, methods, and procedures related to randomized and non-randomized clinical research.

• Capability to propose and implement innovative study designs and advanced statistical methodologies.

• Proficiency in advanced statistical analysis techniques, modeling, and simulation.

• Familiarity with disease areas and regulatory standards.

• Experience leading regulatory and/or reimbursement submissions.

• Exceptional oral and written communication abilities.

• Strong influencing and negotiation skills.

• Excellent business acumen and strategic insight.

• Capability to manage multiple projects and prioritize effectively.

• Ability to lead without direct authority.

• Proficient in navigating a large global organization and fostering partnerships with FSC and EGT members.

🏝️ Benefits

• Retirement and Savings Plan with generous company contributions.

• Comprehensive group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.

• Opportunities for career development.

• Plans promoting work/life balance.