Biotech/Pharmaceutical

Associate Director Statistician, Oncology – Remote

Permanent

Penfield Search Partners

Contact: Barbara Day – 201.784.9028 – bday@penfieldsearch.com

Job Description: The primary responsibilities of this role, Lead Medical Statistician, are to:

  • Take the statistical lead for one or more oncology clinical development projects in the role of project statistician, thus facilitating the overall organization and coordination of all statistical activities regarding the oncology clinical development of the projects;
  • Provide statistical and methodological consultation and contribute to multi-disciplinary and multi-company teams;
  • Facilitate the overall organization and coordination of statistical activities for important studies and projects;
  • Lead virtual teams of statisticians and representatives of other functions;
  • Influence decision making processes during oncology drug development by use of appropriate statistical methodology (e.g. simulations, metanalyses or modeling approaches);
  • Keep abreast of regulatory and methodological issues and ensure communication of these in the respective teams;
  • Identify and implement innovative statistical methodology for the respective field of responsibility, if appropriate in cooperation with academic experts;
  • Lead the development and evolution of standard processes for routine assessments in oncology clinical development as well as project specific standards;
  • Respond to inquiries from health authorities and other internal or external partners;
  • Ensure that the results of clinical trials provide the basis of government approval of each drug and that are presented to conform to strict regulatory (e.g. Food and Drug Administration (FDA), EMA) standards;
  • Design and analyze clinical trials and the writing of statistical reports to be submitted to authorities as a crucial part of our New Drug Application (NDA) for each product Statistics and statistical methodology are thus integral parts of drug development and life-cycle management in order to achieve regulatory approval, scientific acceptance as well as successful product launch and maintenance;
  • Contribute to drug research, the development of new drugs, the approval of new drugs by health and reimbursement authorities and the life-cycle management of marketed drugs according to the major tasks and responsibilities of the position;
  • Facilitate risk management decisions within our company through the development and implementation of innovative statistical methodology.

Required Qualifications:

  • Master of Science or Ph.D. in Biostatistics, Statistics or Mathematics or related field;
  • Excellent interpersonal, leadership and communication skills;
  • Be able to work independently as well as collaboratively, as required;
  • Excellent knowledge of statistical programming languages (including SAS and R);
  • Fluent English skills;
  • At least four years as a statistician with significant time spend in pharma, biotech or similar sector;
  • Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations;
  • Experience in leading teams of statisticians and/or representatives from other functions;
  • High level of expertise in multiple fields relevant for clinical Development.

Tagged as: Associate Director Statistician, Oncology - Remote