Gates Medical Research Institute
Job Title: Portfolio Statistics Lead
Job Number: 28968
Location: 245 Main St Cambridge, MA 02142
Reporting to the Head of Clinical Biometrics, the Portfolio Statistics Lead will work as part of a multidisciplinary team, providing leadership of statistical methodology across multiple programs and provide statistical support to the clinical research portfolio and scientific challenges within the Gates MRI portfolio. Innovation in clinical and translational statistical design and analysis is expected to be a core competency of Gates MRI. The Portfolio Statistics Lead will be a champion of developing and evaluating clinical trial designs, and applying cutting-edge statistical methodology to accelerate translational development and clinical research programs including the routine use of simulation-based trial design, the application of Bayesian methods to define and quantitatively characterize trial stage-gate (go/no-go) decision rules, and the use of advanced statistical learning techniques to identify and validate biomarkers as product development tools. Clearly articulating complex findings within the context of advancing program objectives will be a fundamental capability.
The successful individual will have a broad skillset, spanning the ability to develop and deploy novel approaches to trial design and analysis, the ability to educate team members on the methodological approaches, and the necessary skills to ensure statistical integrity of deliverables from CROs, other outsourcing partners, and global academic, nonprofit and industry partners. The incumbent will be expected to author the statistical analysis plans of Gates MRI sponsored clinical protocols, as well as perform hands-on cutting-edge translational data analyses and use of modeling and simulation approaches to investigated and further product development team (PDT) objectives. They will provide statistically sound methodology and interact with regulatory agencies regarding development strategies for indications that have substantial unmet need. The Portfolio Statistics Lead will also be expected to establish highly collaborative and fruitful partnerships with a diverse set of partners including academia, biotech, pharma, governments, and global health product development partners, including those located in low-income countries.
The successful candidate will be an innovative and collaborative individual who thrives in a “get it done” type of environment with a strong track record of statistical contributions in clinical development and translational medicine. The incumbent will have the following mix of personal and professional characteristics:
- PhD (preferred; minimum 10 years of experience) in Statistics/Biostatistics with at least 6+ years of industry experience in clinical development statistics and a demonstrated track record of bringing innovative approaches to clinical trial design.
- Strong teaching skills to train key stakeholders on statistical methods and approaches that will advance PDT objectives.
- Strong statistical coding skills with the ability to develop statistical methods, simulations and applications on a variety of clinical and translational datasets in R and/or SAS, with guidance.
- Advanced skills in data visualization and graphics, (e.g., SAS GTL, R) for publication quality plots.
- Proficiency in designing adaptive trials and demonstrated ability to work with clinical development, clinical operations and other internal team members on study conduct.
- Experience writing statistical analysis plans, protocols, presentations and publications.
- Specific expertise in early clinical development statistics (e.g., Phase 1 through Phase 3, including proof of concept trials and registrational trials) across small molecules, biologics and vaccines is desirable.
- Experience in infectious disease is preferred.
- Outstanding organizational, project management, and communication skills; ability to work well with a wide range of internal and external stakeholders and build strong partnerships and alliances inside and outside the organization.
- Comfortable working across multiple disease area programs and able to shift gears quickly. Must be open to change and the unknown with a creative and resourceful nature; a self-starter, proactive and results-oriented with high performance standards.
- Strong interpersonal skills with polish and presence; ability to influence others at all levels and lead in a highly matrixed organization.
- Passionate, persistent and tenacious. Strong ability to prioritize and operate with a sense of urgency.
- Extremely bright with a highly strategic nature but also balanced with a biotech mindset and a hands-on, roll-up-the-sleeves style that gets things done.
- Trustworthy with the highest integrity, committed to ethics and scientific standards.
- Demonstrated passion for Gates MRI values with a commitment to deliver results against our mission.