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Job Description
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BIOSTATISTICIAN JOB DESCRIPTION
Job title: Biostatistician
Supervisor: Manager Informatics
Department: Informatics
FLSA Status: Exempt
Our Client Company is offering an outstanding opportunity for a biostatistician looking for a unique career in a well funded, rapidly growing startup. We are a is a medical device company developing novel health monitoring technologies.
Position Description
The successful candidate will take part in two primary projects, device and assay development and statistical algorithm development forming the basis of the company's informatics offerings.
Skills and Responsibilities:
As part of a product development or assessment team, collaborates in the preparation and review of clinical trial result assessments. Provide strategic input into the clinical trial development plan. For assigned clinical trial development project(s), provides sound strategic, statistical and scientific input on project objectives, experimental design, and data analysis to meet project needs and FDA statistical and scientific requirements.
Review all project protocols, author protocol statistical analysis sections and generate study randomizations. Leads team's development of study analysis plans. Assume leadership for the Biostatistics activities related to portions of specific project(s). Reviews case report forms to ensure that protocol objectives are met and project standards are maintained.
Author statistical analysis results in the clinical study reports. The candidate will be responsible for seeing the report through review process and will represent the company at FDA meetings. The candidate will be responsible for statistical input to responses to FDA questions and for statistical content of presentations at Advisory Committee Meetings.
The candidate will also assume statistical responsibility for major segments of a project, e.g. integrated safety/efficacy section of a BLA/NDA. Provides support for investigator publications.
As part of the informatics team, the candidate will collaborate with the systems developers in creating analysis algorithms for mining data from databases -- internal, public and obtained private databases. The candidate should be familiar with sources of health-related databases. Should be familiar with statistical, data mining and machine learning technologies such as regression analysis, clustering, Bayesian filtering, forward and backward inferencing, and decision tree analysis
Additionally, the candidate will encourage and contribute to discussion and preparation of publications and lectures on biometrics issues in clinical trials, both inside and outside of the company. The candidate will engages in research in statistics to improve clinical trial methodology used in the development of client products consistent with corporate priorities and timelines
Requirements:
Masters or Ph.D. in Statistics or Biostatistics
1+ years of industrial development experience.
Software development skills, object-oriented development - Java, Perl or C++. Web development skills are a plus.
Familiarity with statistical programming packages such as R, S, SAS, SPS
Familiar with DBMS systems and the SQL language. Experience with MySQL is a plus.
Experience in programming and building models using MATLAB a plus
Candidate must possess strong communication skills in order to convey complex analytical results to business sponsors of programs
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