US-NJ, Senior Principal Biostatistician, Clinical Pharmacology, Early Develop 219102BR-MZ
Senior Principal Biostatistician, Clinical Pharmacology, Early Develop
Global Drug Development
East Hanover, NJ
Research & Development
Apply expertise in theoretical and applied statistics for study designs and analyses to characterize the pharmacokinetics and its relationship with safety / efficacy / biomarker endpoints of compounds in clinical development from early to late phases for indications in Oncology and Hematology. Design, plan and execute biostatistical components of plans for R&D projects for determining safety, efficacy, and marketability of pharmaceuticals / biologics. Responsible for all statistical tasks on the Clinical Pharmacology (CP) components of assigned compounds including CP and non-CP clinical studies: clinical trial design / planning, analysis plan, reporting activities including exploratory analyses and additional analyses to support dose/regimen determination, Health Authority (HA) interaction, submission, publications, and statistical consultation throughout entire drug development. Promote and implement innovative approaches to study design, data analysis and dose / regimen determination, as well as opportunities for modeling and simulation. Take on major functional excellence initiatives such as process improvement as required. Track clinical trial activities and ensure milestones are reached for all statistical deliverables with high quality. Develop statistical analytic solutions including operating characteristics and scenario assessments to support optimal clinical trial and decision criteria for clinical development of indications / projects. Utilize programming languages and statistical software packages including SAS, R, nQuery. Work with statistical scientist and programmer to develop and execute project-level statistical planning documents and ensure statistical reporting deliverables (tables, listings and graphs) to support decision-making. Mentor junior biostatisticians as required, and drive operational excellence. Apply knowledge and expertise in mixed effects modeling, Bayesian modeling, non-linear regression, non-parametric analysis, clustering techniques, statistical methods for high-throughput screening and assay validation, time-series analysis and spatial statistics. Prepare statistical protocols in development-phase projects. Organize and interpret data into tabular forms amenable to principles of statistical inference. Responsible for reporting statistical components describing studies, outcomes and methods used. Provide specifications and directions to clinicians / statistical programmers as needed. Participate and collaborate in program design and in establishing standards for clinical conduct, and collection, management and/or reporting of data. Follow processes and adhere to Novartis and project specific standards as well as HA requirements (SOPs, Business Guidance, MAP, GCP, regulatory guidelines). Establish and maintain sound working relationships and effective communication with project teams. Participate in non-clinical project activities as needed.
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.
Candidate must have PhD or foreign equivalent degree in Statistics, Biostatistics, Statistical Genetics or related field, and minimum 3 years of industry experience and demonstrated expertise in theoretical and applied statistics for study designs and analyses to characterize Clinical Pharmacology of pharmaceuticals and biologics in clinical development for Oncology, including: statistical components of clinical studies for characterizing Pharmacokinetics of assigned compounds; statistical components of clinical studies for determining relationship between safety/efficacy and dose/exposure; trial design/planning, analysis plan, reporting including exploratory analyses and analysis to support publications; statistical techniques including mixed effects modeling, Bayesian modeling, non-linear regression, non-parametric analysis, clustering techniques, statistical methods for high-throughput screening and assay validation, time-series analysis, spatial statistics; programming languages and statistical software packages including SAS, R, nQuery. Must have demonstrated knowledge and experience in drug development and HA guidelines, mentoring junior statisticians, and success working w/cross-functional teams of clinicians, statistical scientists and programmers.
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