28 days ago on jobs.actelion.com

Associate Director, Expert Statistician

Actelion Pharma Schweiz AG

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Associate Director, Expert Statistician

Associate Director, Expert Statistician   -   ( 1700009W )
 
Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for Expert Statistician.
 
As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.  Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.
 
Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.
 
 
Job Responsibilities
 
  • Independently represent statistics function on global teams (e.g. clinical trial/project or life cycle teams) in support of clinical trials, indication level programs directly in full compliance with Actelion processes
  • Play a leadership role in the development and review of study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, registration and disclosure of study results in internal and public registries, ensuring accurate and statistically valid deliverables
  • Take ownership of statistical and scientific robustness either directly as a trial statistician, project statistician, or in a supervisory role
  • Manage functionally a group of statisticians and programmers at various levels with respect to deliverables, processes, and professional development, and mentor staff as required
  • Interacts with regulatory authorities on statistical issues on assigned projects/TAs
  • Provide Resource Plans and timelines for deliverables for assigned projects
  • Be accountable for quality and timeliness of various deliverables and milestones under her/his responsibility
  • Lead or support continuous improvement, acceleration and quality of working procedures and outputs in the area of statistics
  • Maintain / develop a high standard of statistical methodology

 
Candidate Requirements
 
  • PhD in Statistics or Life Science, or Master Degree in Statistics or equivalent qualification
  • In-depth knowledge in Statistics, and its applications to clinical trials in at least two therapeutic areas (preferably at least 10 years of experience in clinical trial development in the Pharmaceutical Industry or Clinical Research Organizations)
  • Excellent knowledge of international clinical research regulations and requirements
  • At least five years as a Senior Statistician, (i.e., above Statistician level) in Clinical Development in the Pharmaceutical Industry, or Clinical Research Organizations
  • Experience gained in the tasks of Project Statistician (at least 2 years)
  • Good project management skills and excellent oral and written communications skills in English
  • Good working knowledge and understanding of SAS and of software for sample size estimations
  • Advanced knowledge of clinical study designs, common statistical analysis methods, descriptive and inferential statistics with experience of innovative design and/or analysis methodology implementation in clinical development
  • Good knowledge of statistical programming languages (including SAS, R), software, techniques, and processes.
  • Working knowledge of UNIX operating systems, and common software products and technologies (e.g., Microsoft Office products)
  • Strong project management skills
  • Strong collaborative skills and ability to work with a cross-functional team
 
 
 
 
 
If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your application.
 

Primary Location

:   CH-BL-Allschwil

Job

:   Clinical Development

Schedule

:   Full-time

Job Type

:   Standard

Job Posting

:   Nov 21, 2017