Associate Director, Biostatistics
Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life processes of plants, animals, and humans. In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and software. Organizes and interprets data into tabular forms amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. Provide specifications and directions to the clinicians/statistical programmers. May partner in program design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.
Responsible for all statistical tasks on the assigned clinical trials: clinical trial design/planning, analysis plan, reporting activities including exploratory analyses, and additional analysis to support publications. Provide statistical consultation to clinical team and support decision making process by providing adequate information. Track clinical trial activities and milestones. Ensure timeliness and adequate quality of all Biometrics and Data Management (BDM) deliverables for the assigned trials. Follow processes and adhere to Novartis and project specific standards as well as Health Authority requirements (SOPs, Business Guidance, Master Analysis Plan, GCP, and regulatory guidelines). Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and BDM team. Participate in non-clinical project activities as needed. Application and extension of existing Bayesian methods for dose finding and proof of concept. 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.
Requirements:
Minimum requirements PhD in Statistics Fluent English (oral and written). 4-8 years; knowledge and expertise in Statistics, in particular the use of applied Bayesian statistics in decision making. Knowledge of statistical software package (e.g. WinBUGS, R, SAS). Good communication skills. Able to work with a multidisciplinary team to achieve team's objective.
