Biostatistician Genocea Biosciences, Inc.
We are looking for a Biostatistician to provide statistical expertise and leadership to project and analysis team. This individual will provide statistical consulting and technical support as it relates to the design and statistical analysis of clinical studies. They will review, edit, or work with external vendor to develop analysis and data presentation specifications for SAS programming. The Biostatisician is expected to perform analysis, interpret study results. They may be responsible for more than one study.
Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.
Experience with, and mastery of, statistical methods commonly used in the analysis of data obtained from Phase I ? IV clinical trials.
Experience with SAS Base and SAS Stat, as well as strong data step skills.
Experience with other statistical software packages, such as N-Query, S-Plus.
Ability to work creatively and independently to carry out assignments of a complex nature.
Ability to work effectively and cooperatively with other professional staff members.
Ability to communicate effectively, both verbally and in writing, with all levels of staff and with the public.
Degree requirements include one of the following:
Masters-level degree in Statistics, Biostatistics or related field with 6 years relevant work experience; total work experience to include 2 years in CRO industry or biotech
Collaborates with program staff on the implementation and analysis of statistical aspects of research protocols.
Provides statistical consultation for pre-clinical and clinical programs, including but not limited to protocol development, randomization, sample size assessments, efficacy evaluations, and data review.
Provides input to project timelines, and ensures that project timelines for biostatistics deliverables are met for both internal and external clients.
Ensures the accurate programming of SAS clinical data extracts and data displays.
Develops statistical analysis summary and analysis plans, including textual description of planned analysis and mock-ups of data displays.
Reviews and provides comments on statistical summaries and analysis plans.
Develops programming specifications to summarize the results of clinical trials, including analysis datasets and tables/listings/figures.
Performs statistical analyses, including hypothesis testing and modeling.
Provides tabular and written summaries of analyses and statistical methodology for Clinical Study Reports.
Interacts with Medical Writers to ensure appropriateness of data inferences.
Writes pertinent sections of a clinical study report
Conducts exploratory analyses from study datasets to develop additional hypotheses for future studies.
Interfaces with regulatory agencies as the project biostatistician.
Location: Cambridge, MA
||161 First Street |
Cambridge, MA 02142