The Principal Biostatistician is responsible for leading, developing and implementing statistical solutions to optimally support clinical trial and decision criteria for Phase I-Proof of Concept. They are responsible for the statistical scientific and operational aspects of multiple trials which include leading the discussion and implementation of modern and innovative trial designs, statistical models, analysis and data exploration methodologies, in line with the research objectives of the clinical trial(s), developing and executing analysis plans and ensuring statistical reporting deliverables for clinical study reports produced to support decision making.
1. Support clinical and statistical team in protocol writing. 2. Accountable for developing analysis plans for Phase I-Proof of Concept clinical trials and performing these tasks with a high level of independence. 3. Accountable for CSR deliverables from statistics. 4. Ensure statistical deliverables for multiple studies are delivered with high quality and to the agreed upon timelines while following processes and standards 5. Represents department at trial level internal/external meetings for strategic statistical scientific inputs. 6. Establish and maintain efficient interfaces with internal and external customers. Support statistical research by providing advice and contributing to computational aspects as well as contributing to the statistical scientific content for internal decision boards/regulatory/submission documents. 7. Provide statistical analysis solutions when exploratory analyses are required. 8. Be aware and knowledgeable of advances reported in statistical literature.
1. High quality, timely and influential biostatistician contributions. 2. Application of high quality methodology in the assigned clinical trials that is integrated with the disease area. 3. Effective communication 4. Contributions to exploratory analyses 5. Contributions to operational excellence and to Strong IQS team dynamics
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.
PhD (in Statistics or equivalent) required with at least years of relevant work experience preferred. MS (in Statistics or equivalent) with additional years of experience may be considered; however, PhD level candidates will be given stronger consideration . Candidate should also have exceptional communications skills in English and a minimum of 3 years experience is necessary for PhD candidate. A minimum of 5 years experience is required for Masters candidates
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