Requisition ID 36660BR
Title Principal Statistician
Job Category Biostatistics and Data Management
Job Description PURPOSE:
This is a senior level technical position. Work under minimal supervision, the incumbent is responsible for the delivery of statistical support to NN's clinical development, registration, and marketing support programs. Functions include clinical trial design, data analysis, report writing, and general consultations. The scope of responsibility includes one or more drug development programs. SCOPE: The scope of responsibility includes one whole drug development programs. INDEPENDENCE: Minimal supervision required. Able to direct the statistical activities for a complete drug development project.
Reports to the head of Biostatistics or a Director of Biostatistics. Through project team, works closely with clinicians, medical writers, data managers, regulatory managers, and marketing managers.
* Under coordination of his/her supervisor, lead the statistics aspect of assigned clinical projects. Assure that statistical and scientific methodologies are fully considered and documented. Under minimum supervision, participate in the review of study protocols, critic and suggest improvement on scientific methodology, write statistical sections, develop plans and perform statistical analysis and presentation. Under guidance, participate the interaction with medical development, medical writing, regulatory affair, and regulatory agencies. Assure statistical input, analysis, and report of the highest quality are delivered according to schedule.
* Under coordination of his/her supervisor, participate in meetings or communications with the regulatory agencies (primarily the FDA). Under minimum supervision, manage the relations with NNPI internal customers, including clinicians, medical writers, regulatory staff, and marketing managers.
* Participate in the development and update of internal SOPs and working procedures. Assist the head of Biostatistics, lead the department staff keeping abreast with current statistical literature, assure the most current regulatory requirement are followed and sound methodologies are adopted. Keeping abreast and observe general guidance established in the pharmaceutical industry, including FDA guidelines, ICH guidelines, NN SOPs, and generally accepted GCP.
* Under coordination with his/her supervisor, prioritize task assignment, timelines, and outsourcing management. Manage the interactions with NNA/S headquarters statistical group through department Director.
* Perform hand-on programming or direct statistical programming staff assure that data listing, tables, and graphs are produced with highest efficiency and quality; Participate in the development and maintenance of statistical routine libraries.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
* A Ph.D. degree in biostatistics, statistics, or relevant areas required.
* Demonstrated ability to develop statistical methodology for analyses of clinical data.
* Extensive knowledge of statistical computer programming skills.
* Good communication and interpersonal skills.
* Knowledge of regulatory requirement.
* Knowledge of statistical concepts and techniques and of clinical trial principles.
* Six years of experience in pharmaceutical industry engaged in biostatistical support of clinical development with progressively increasing scope of responsibility.
Department CMR - BIOSTATISTICS & STATISTICAL PROG
Position Location US - Princeton, NJ
State/Provinces US - NJ
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
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