Sr Principal BioStatistician

Organization
Novartis
Job Location
East Hanover, NJ
Job Description

The Senior Principal Biostatistician is responsible and accountable for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. Works independently at the trial level and may lead indication or project level statistical activities for a development project under limited supervision. 

Proposes and leads implementation of modern and innovative trial/experimental designs, statistical models, analysis and data exploration methodologies at the study or project level. 

Impact on the organization: 

1. High impact by leading the statistical scientific activities: planning, evaluation, risk mitigation, health authority acceptability for trials and indications. 
2. Timely delivery of high quality statistical deliverables to meet the needs of the clinical trial team. 
3. Acceptability of clinical study report and documentation by Health Authorities including exploratory trial level deliverables. 
4. Efficient design, analyses, and reporting leading to quality decisions and submissions, and reduced time and costs for development and registration. 
5. Ensuring quality reputation of Novartis with Health Authorities and other external partners. 

THIS POSITION CAN BE FILLED AT A LEVEL COMMENSURATE WITH EXPERIENCE 

LOCATION IS FLEXIBLE TO EAST HANOVER, NEW JERSEY OR CAMBRIDGE, MA 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 Education 

PhD (in Statistics or equivalent) with 0 to 3+ years relevant work experience preferably in the pharmaceutical or health care industry 

MS (in Statistics or equivalent) with 0 to 7+ years relevant work experience 
preferably in the pharmaceutical or health care industry 

candidates with PhD will be given stronger consideration 
Languages: Fluent English (oral and written) 
Good communication and presentation skills. 

Experience/Professional 
Requirement: 1. Influences decisions that directly impact the trial/project and team ability to deliver objectives. 
2. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modeling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e.g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. 
3. Good understanding of Franchise/Therapeutic Area and or regulatory activities. 
4. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. 
5. Good business ethics. 

THIS POSITION CAN BE FILLED AT A LEVEL COMMENSURATE WITH EXPERIENCE 
LOCATION IS FLEXIBLE TO EAST HANOVER, NEW JERSEY OR CAMBRIDGE, MA

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