Associate Director Statistical Scientist

Profile

A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement. Think what's possible. Novartis and its associated companies are always looking for talented employees globally. We are engaged in advance preparation for potential position openings. Submit your CV/resume now to join our talent pool for the position described below. Please note that you are not applying for a current vacancy, but are submitting your CV/resume for consideration for future, possible opportunities. We look forward to receiving your information. Novartis is an Equal Opportunity Employer.
The Associate Director Statistical Scientist is the global lead for the statistical strategy of multiple indications (or equivalent) within (pre/early/full) clinical development. They are responsible for the discussion and implementation of modern and innovative trial designs, statistical models, and analysis methodologies that optimize the drug development program for each indication. They set the strategic direction for addressing statistical issues in regulatory submissions, and directly influence drug development decisions with internal and external partners. They may act as CSU Statistician
Provide strategic statistical scientific global leadership to the clinical development programs, comprising all relevant technical and disease area knowledge Drive and steer the strategic quantitative framework for (pre/early/full-) clinical programs in close collaboration with (early) project teams Represents the GPT internally and externally as the statistical scientist with leading quantitative skills, including regulatory interfaces, with objective and transparent program quantitative risk/probability of success assessments In collaboration with clinical counterparts (Global Brand/Project Medical Directors/ Translational Medicine Experts) and Global Project Teams, influence and negotiate clinical development plans (CDPs/TPPs). Leads the quantitative evaluation of competing program/trial/analysis strategies assuring robust clinical development planning and execution. Defines and drives 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), Drives the full integration of modern aspects of drug development including model-based drug development and statistical methodologies in collaboration with partners, facilitates and manages internal and external stakeholders through to PoC/DDP or regulatory acceptance. Drives and coordinates the synthesis and integration of information to support transition of drug development milestones / decision boards. Identifies alternative strategic options to risk mitigate programs – thus limiting potential negative impact on (pre/early/full-) program success Leads statistical scientific evaluation of in-licensing opportunities Represents IIS at project level internal/external meetings with respect to statistical scientific input and in portfolio level governance boards (e.g TM forum, IFB) Ensure full integration of Statistical Methodology, make sure that the IIS team (biometrician, data management, database programming, statistical programming, medical and scientific writing are aligned. Interacts with Health Authorities and external key opinion leaders as the recognized Novartis expert at the program (or equivalent) level for all quantitative aspects of the program.
EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum requirements
PhD in Statistics (or equivalent degree/knowledge)
Fluent in English (oral and written).
1. 8 years industry experience
2. 4 years influencing (pre/early/full-) clinical development programs establishing, and regulatory approvals with global leadership of the statistical sciences within the development plans, within at least one indication/disease area. Strong disease area and guidelines knowledge.
3. Contributes to external white-papers/policy shaping best practice statistical science. Has strong and established track record of developing/establishing statistical excellence. Established experience in leading global scientific improvement/change initiatives
4. Strong 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 the (pre/early/full-) clinical development strategy. Strong 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 environments
7. Expert skills to facilitate and maximize the contribution of quantitative team
8. Hands-on experience in leading the interface to regulatory agencies/leading the early clinical development campa

Company info