Manager, Biostatistics

Location
Basking Ridge, New Jersey
Posted
Nov 22, 2021
Ref
REGEA0026R2053
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time

The Biostatistics and Data Management group is looking for a Manager, Biostatistics to support exploratory statistical analyses within Global Clinical Development.  This a position with high visibility for a qualified statistician to collaborate in cross-functional drug development teams to develop and execute innovative statistical analyses of clinical trial and related data.   The incumbent will work with teams from all phases of development as well as new therapeutic areas.

Responsibilities:

  • Work with cross-functional teams to articulate drug development questions, frame statistical approaches to address those questions, and analyze the resulting data, primarily focused on supporting development strategy across all therapeutic areas and phases of development, from preclinical through post-marketing.  
  • Take initiative on statistical thinking for all aspects of the exploratory analyses, including identification of the scientific questions, identification of data sets to support the questions, development of statistical plans, and interpretation and communication of the results
  • The incumbent will provide strategic input and leadership on statistical methods, analyses and interpretation of large and complex data sets from clinical trials in various disease areas and stages.
  • Identify and apply novel analysis/modeling techniques for interpreting clinical data and enhancing tools for decision making in development programs that span therapeutic areas, from early clinical to completed phase 3 clinical trials.
  • Develop and maintain good working relationships with clinical scientists, therapeutic biostatisticians, and external collaborators to drive program strategies and decisions.  Proactively seek inputs from other experts within and outside the group on various projects and research activities, and share technical information when appropriate.
  • Maintain and expand expertise in various computing tools to leverage internal and external data sets to drive decisions. Examples of such tools include R, R/Shiny, WinBUGS, JAGS, SAS, EAST, nQuery, etc.
  • Develop innovative statistics methodologies or clinical trial designs for drug discovery, present at management and team meetings, co-author publications and influence the external pharmaceutical industry and regulatory environment through participation in professional associations, conferences, and publications.

Requirements:

  • PhD in Statistics, Biostatistics or a related field
  • 2+ years of relevant experience
  • Solid knowledge of statistical analysis methodologies and computational statistics. The ideal candidate will have an experience in statistical computing, modeling and simulation, linear and nonlinear models, and model-informed drug development
  • Familiarity with data mining or machine learning algorithm preferred. 
  • Expertise in software for statistics or data science, such as R, Matlab, Python, or SAS, is required.  Familiarity with high performance computing is preferred. 
  • Ability to translate scientific questions into statistical hypotheses and analyses. 
  • Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, and effective communication and presentation skills.
  • Excellent influence and leadership skills, with a track record of collaboration with scientists and researchers at Principal Biostatistician level.