Associate Director Biostatistics - Los Angeles, CA, United States - Proclinical Staffing

Description

Associate Director Biostatistics - Permanent - Remote
Proclinical Staffing is seeking an Associate Director Biostatistics to join a cutting-edge pharmaceutical company. This is a permanent role with the opportunity to work remotely.

The Associate Director, Biostatistics is responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.

D. in Biostatistics or Statistics or Equivalent with at least 7 years pharmaceutical biostatistics experience; Experience programming in SAS.
Proficiency in R programming language and other statistical software, including EAST.
Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities.
Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials.
Contributes to or prepares statistical analysis plans.
Collaborates with Data Management, Clinical Development and Clinical Operations on design of eCRFs.
Collaborates with Statistical Programmers on summary and analysis of trial data.
Writes ADS and ad hoc analysis specifications.
Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
Contributes to scientific articles, summarizing data collected in trials.
Manages CRO statistical and programming support.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.