The Senior Principal Statistical Scientist is the global lead for the statistical strategy of an indication (or equivalent) within (pre/early/full) clinical development.
They are responsible for the discussion and implementation of modern and innovative trial designs, statistical model-based drug development approaches, and analysis methodologies that optimally address the research objectives of the clinical trials and support the goals of the indication.
They provide statistical strategies for regulatory submissions, and contribute to drug devel-opment decisions with internal and external partners.
They may act as CSU Statistician
1. Provide strategic statistical scientific global leadership to clinical indication (or equivalent) development, comprising all relevant technical and disease area knowledge
2. Drive and steer the strategic quantitative framework for the suite of clinical trials in close collaboration with (early) project teams
3. Represents the GPT/GCT/CTT (or equivalent) internally and externally as the statistical scientist with leading quantitative skills, including regulatory interfaces, with objective and transparent clinical trial quantitative risk/probability of success assessments
4. In collaboration with clinical counterparts (Global Brand/Project Medical Directors/ Translational Medicine Experts) and Global Project Teams/GCT/CTTs, influence and negotiate clinical trial designs aligned with the CDPs/TPPs. Leads the quantitative evaluation of competing trial/analysis strategies assuring robust support to clinical development planning and execution. Contributes to the clinical development plan of the indication Contributes to the statistical strategic and quantitative contributions to regulatory/submission strategy and related documents (e.g.: Target Product Profile, sPOC document, CDP, Briefing Books, Risk Management Plan and responds to HA questions).
5. Across the multiple trials within the indication (or equivalent), is responsible for the full integration of modern aspects of drug development including model-based drug development and statistical methodologies in collaboration with partners.
6. Contributes to the statistical scientific requirements, synthesis and integration of information to support transition of drug development milestones / decision boards.
7. May lead statistical scientific evaluation of in-licensing opportunities
8. Represents IIS at indication level internal/external meetings for strategic statistical scientific inputs
9. Identifies opportunity and integrates Statistical Methodology where necessary, make sure that the IIS team (biometrician, data management, database programming, statistical programming, medical and scientific writing are aligned on the statistical scientific part.
10. Interacts with Health Authorities and external key opinion leaders as the recognized Novartis expert at indication (or equivalent) level for all quantitative aspects of the program. represents IIS at across global regulatory hearings/advisory committee meetings and other global regulatory interfaces
11. Provides biostatistics and drug development expertise to infrastructure and process improvement initiatives
12. Provides technical statistical expertise, identifies opportunity for influencing internal discussions for white papers/regulatory policy. Establishing external presence for technical / strategic areas
13. May serves as mentor and may undertake role of development/appraisal coordinator for selected IIS Franchise associates
14. May act as CSU statistical scientist
Key Performance Indicators
1. Quality and timeliness of statistical contribution/influence and implementation of robust, high quality indication level clinical development approaches (program/trial/analysis strategies) including quality lead contribution at scientific and regulatory meetings, as assessed by the respective Clinical Program lead and/or by the IIS Program Head
2. Pro-active and role-model indication level presentation of statistics in the Project Teams/GCT/GPT, as assessed by the respective Clinical Program lead and/or by the IIS Program Head
3. Application of high quality methodology in the assigned indication/therapeutic area: cutting edge statistical methodology, innovative designs, creative project plan solutions, integrated disease area understanding, and health authority acceptability
4. Strong IIS team dynamics to support robust Clinical Program as assessed by team colleagues
5. Effective coaching and development of statisticians (statistical scientists and biometricians), as assessed by the IIS Program Head
Number of associates: No direct reports. 3 to 10 matrix management
Impact on the organization:
1. High impact by leading the statistical scientific: planning, evaluation, risk mitigation, health authority acceptability for indications
2. Timely, efficient clinical development programs. Quality drug development milestone transitions, submissions, reducing the time and cost for development/ registration/ commercialization and increasing probability of approval
3. Increased quality of decisions: in-licensing, early stopping of non promising trials/indications
4. Increased commercial value of brands Minimum requirements Ideal Background
Education (minimum/desirable): PhD in Statistics (or equivalent degree/knowledge)
Languages: Fluent in English (oral and written).
1. 5+ years industry experience
2. 2+ years influencing at least indication level clinical development programs with global leadership of the statistical sciences within the clinical development plans. Good disease area and guidelines knowledge.
3. Contributes to external white-papers/policy shaping best practice statistical science. Is establishing track record of developing/ embedding statistical excellence. Established experience in contributing to global scientific improvement/change initiatives
4. Very good interpersonal and communication skills (verbal and writing) bridging scientific and business needs – integrating quantitative sciences, strong disease area knowledge and appropriate market/competitive intelligence
5. Expert scientific leadership skills demonstrated in facilitating and optimizing indication strategy. Good track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies
6. Natural modern leadership style building partnerships and collaborative working environments
7. Strong skills to facilitate and enable the contribution of quantitative teams
8. Hands-on experience in contributing to the interface to regulatory agencies/leading the indication-level early clinical development campaign
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...