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Statistician REMOTE
Cambridge, MA  Posted: 5/7/2020


 A Leading Pharmaceutical Company has an opening for a Sr. Statistician Remote.  
As a seasoned Biostatistician , you will leverage your knowledge and experience in applying advanced statistical methods and SAS skills to lead or help drive one or more Phase I-IV trials, with a focus on CNS or Immunotherapy studies.
You will contribute by:
  • participating in the development of study protocols, including participation in study design discussions and sample size calculations;
  • reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
  • performing statistical analyses;
  • interpreting statistical results;
  • preparing clinical study reports, including integrated summaries for submissions (ISS/ISE), other documents for Health Authorities, Publication or exploratory purpose;
  • leading study activities when called upon;
  • perform QC and oversight of other third parties' contributions as appropriate
  • utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms and to provide strategic statistical input to teams;
  • serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
  • participate in special initiatives requiring statistical input as appropriate
  • being adaptable and flexible when priorities change
What we are looking for:
  • Master’s degree in statistics or a related discipline. PhD desirable.
  • 5-10 years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
  • ISS/ISE experience required
  • 3+ years of Study Lead experience working with cross-functional teams.
  • Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
  • Knowledge and implementation of advanced statistical methods.
  • ISS/ISE experience.
  • Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
  • Strong knowledge of ICH guidelines.
  • Solid understanding & implementation of CDISC requirement for regulatory submissions.
  • Adept in ADaM specifications generation and review and/QC of datasets.
  • Effective communicator: able to explain methodology and consequences of decisions in lay terms.
  • Team player; willingness to go the extra distance to get results, meet deadlines, etc.
  • Ability to be flexible when priorities change and deal with ambiguity

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