Director/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.The Director Statistical Scientist drives the strategic statistical scientific integrity across multiple disease areas within a Franchise or equivalent (within a program across Franchises), influence shaping and negotiating (pre/early/full-) clinical programs, optimizing the contribution from drug development scientists by fostering robust strategies in achieving regulatory and/or significant early and late stage drug development milestones. They lead the identification and definition of state-of-the art quantitative solutions including, model-based approaches drug development able to move seamlessly across the disease areas across the Franchise and are mentors and consultants to multiple clinical programs and the Franchise level senior leadership team
Lead the Core Analytics contributions to, and facilitates the direction of, robust clinical development planning, seamless integrating all relevant technical and disease area knowledge Drive, steer and mentor others in developing strategic quantitative frameworks for (pre/ early/ full-) clinical programs in close collaboration with (early) project teams and management Represent clinical/submission team in drug development science at regulatory interfaces/ external engagements, with objective and transparent strategic clinical program assessments using quantitative risk/probability of success assessments As partner to senior clinical leadership (Global Brand Medical Directors/ Translational Medicine Heads), influence and negotiate clinical development plans (CDPs/TPPs). Leads and facilitates teams in the definition and quantitative evaluation of competing program/trial/analysis. Negotiate product strategic using strategic statistical scientific consulting providing quantitative contributions to regulatory/submission strategy and related documents: Target Product Profile, Briefing Books, Decision criteria, project and trial designs, Risk management plan, responses to Health Authority questions, and Life Cycle management. Identify opportunity, foster and drive the full integration of modern aspects of drug development including model-based drug development and statistical methodologies in collaboration with partners; facilitate and manage internal and external stakeholders through to PoC/DDP or regulatory acceptance. Lead advanced decision making support using modern synthesis techniques and provides support to global program heads and project teams at drug development milestones / decision boards. Identify and facilitate risk-mitigation combining quantitative sciences and disease area/competitive landscape knowledge Foster the integration of Statistical Methodology, make sure that the IIS team (biometrician, data management, database programming, statistical programming, medical and scientific writing are aligned on the statistical scientific part. Interact with Health Authorities and external key opinion leaders as the recognized Novartis expert within the Franchise (or equivalent) Identify and lead next generation opportunity for infrastructure / process / scientific consulting improvement initiatives Provide technical statistical expertise, leadership and serves as a role model and mentor to statistical scientists May act as lead CSU statistical scientist.
Quality, timeliness and targeted robust, high quality (pre/early/full-) clinical development strategies (program/trial/analysis strategies) including consulting and leadership contribution at scientific and regulatory meetings, as assessed by the respective (pre/early/full-) clinical management and/or by the IIS Program Head Pro-active and role-model disease area level presentation of statistics across multiple disease areas as assessed by the respective (pre/early/full-) Clinical Program lead and/or by the Biostatistical Sciences Gropu Head and application of high quality methodology across multiple therapeutic areas: cutting edge statistical methodology, innovative designs, creative project plan solutions, integrated proficient disease area understanding Strong IIS team dynamics to support robust (pre/early/full-) Clinical Program as assessed by team colleagues Effective role modeling, coaching and educational development of statisticians (statistical scientists and biometricians), as assessed by the Biostatistical Sciences Group Head Strong track record of innovative, tailored clinical development planning based on sound quantitative science principles and seamless integrated of disease area knowledge Record of successfully contributing to a drug development scientist culture, as assessed by Biostatistical Sciences Group Head Novartis is an Equal Opportunity Employer.
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) English 1. Director - 10 years industry experience /Associate Director 8 2. 6 years ( Director), 4 (Associate Director) negotiating and influencing (pre/early/full-) clinical development programs establishing, with global leadership of the statistical sciences within the development plans, across multiple disease areas. Strong disease area and guidelines knowledge. 3. Track record in identifying and leading contribution to external white-papers/policy shaping best practice statistical science. Has internally and externally 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 bridging scientific and business needs – integrating quantitative sciences, strong disease area knowledge and appropriate market/competitive intelligence

Company info

USA Novartis Clinical Operations Inc East Hanover NJ

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