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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