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Joseph Associates Inc. - Executive Search Firm
I n t e g r i t y  -  C o m p e t e n c e  -  K n o w l e d g e  -  E x p e r i e n c e 

Clinical research statistician

Location: Princeton, NJ
Job Type: Direct Hire
Salary: $10,000.00 - $145,000.00
Degree: Master;
Date: 1/31/2017
Job ID: 02446701
Job Description
From the confidential files of Joseph Associates, Inc., Contact: Joe Nakelski, 631 351-5805x1, Joe@JAexecutiveSearch.com
 
Job Title-Director of Clinical Statistics and Disease Modeling                Job Reports To-Chief Clinical Officer
 
Job Location-The position will be based in Princeton, N.J. with occasional travel to Client’s other offices and meeting with collaborators.
 
Job Description
My Client oversees a portfolio of projects aimed at understanding the natural progression of a specific neurological disease, developing the best biomarkers and endpoints for use in clinical trials, and working with external partners to develop and execute clinical development plans for novel therapeutics. Furthermore, Client has a large portfolio of scientific and preclinical projects, which generate a significant volume of data. The team engages a diverse array of partners to help manage this extensive portfolio, including academic institutions, government agencies, CROs, biotech and pharmaceutical companies.
 
We are seeking a highly motivated individual to work closely with scientists, project managers and data managers at Client, and with the broader neurological disease scientific community, to help educate and set strategic direction for using biostatistics, disease modeling, clinical simulation and other methodologies to thoughtfully advance clinical research in this neurological disease.  Using their extensive knowledge and experience, along with a collaborative approach, the successful candidate will help Client achieve its mission. 
 
This recognized leader will mentor and motivate staff and maintain excellent working relationships with collaborators both internal and external to Client.  They will create and maintain a positive work environment and contribute to the successful design of both clinical and pre-clinical studies.  They will keep abreast of new developments in the field, as well as, the regulatory environment to identify and implement improvements. 
 
The position offers involvement in a novel model of non-profit orphan disease drug discovery development and an entrepreneurial work environment with high impact.
 
Job Responsibilities
  • Serve as a role model and mentor to statisticians, other scientists and collaborators. Encourage personal development, promote teamwork, quality and motivation.
  • Review and develop statistical analysis plans – for clinical and pre-clinical projects.
  • Oversee the Client’s portfolio of biostatistics, clinical modeling and simulation projects, and provide assistance as requested to pre-clinical projects.
  • Represent the Foundation to help shape clinical modeling and statistical activities working with external parties, including Client collaborators, CROs and regulatory agencies.
  • Facilitate and QC output for publications; review publications to insure accuracy, quality and soundness of statistical methodologies.
  • Partner with data management personnel and collaborators in the preparation of high quality, user friendly datasets.
  • Maintain awareness of industry and regulatory standards, new computational and data modeling approaches, as well as learn, develop and support Client’s internal SOPs.
 
Qualifications
  • Masters or Ph.D. in Statistics, Mathematics, PharmD, or related field with at least 10 -15 years performing statistical analysis for clinical studies and/or disease progression modeling
  • Excellent and positive interpersonal and communication skills.
  • Ability to work in a matrix organization and cross-functionally identify and resolve issues.
  • Desire and solid track record of effectively mentoring scientists.
  • Demonstrated ability to thrive in a fast-paced environment to effectively achieve aggressive goal.
  • Flexible, well organized, with strong time management and multitasking skills.
  • Demonstrated ability to effectively contribute to statistical aspects of clinical protocol design, data interpretation, and review and reporting of results from clinical and pre-clinical studies.
  • Practical experience with the application of advanced statistical methodologies for clinical study design/analysis, pre-clinical study design/analysis, disease progression modeling, and clinical trial simulation.
  • Proficiency in SAS or R as well as a working knowledge of relevant computational, clinical simulation and modeling, data visualization tools including NonMem, PsN, and Phoenix.
  • Strong understanding of FDA regulations, GCP, ICH, CDISC and 21CFR part 11
  • Experience in working on neurological diseases a plus
  • Pharmaceutical or biotech experience a plus
 
 
Joseph Associates Inc.
229 Main St. Huntington, NY 11743

Phone: 631-351-5805   |   Fax: 631-421-4123   |   Email:  Inquiries@JAexecutivesearch.com