As a Biostatistician at Premier Research, you’ll have the unique opportunity to work on NDA submissions to engage with studies at the program level preparing Clinical Summaries of Safety (ISS) and Efficacy (ISE).
Our Biostatisticians apply knowledge of statistics to independently provide statistical consulting, assist with study design and protocol development, and perform statistical analysis of clinical trials.
They will also review project related documents, prepare statistical analysis plans (SAPs) and statistical reports. This individual will develop analysis data specifications, create analysis datasets, Tables, Listings and Graphs (TLG) of clinical trial data using SAS.
He or she will also perform quality control of TLGs and derived data sets created by others; Develop and validate SAS programs, micros, and utility tools;
Apply advanced programming knowledge to support programming efficiencies.You'll be accountable for : Independently providing statistical consultingPreparing statistical sections of protocols, performing sample size and power calculation for studies, and creating randomization schedule per study design and relevant specificationsReviewing protocols, case report forms (CRFs), data management plans, data specifications and other related study documentsIndependently developing statistical analysis plans (SAP) in accordance with the protocols and SAS programs to develop statistical models and complete statistical analysesSupporting integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissionsIndependently preparing analysis data specificationsDeveloping SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SASYou'll also be Responsible for : Performing quality control of analysis data and TLGsPreparing statistical reportsReviewing, providing input and interpreting of analysis result to clinical study reportYou'll Need this Background to be Considered : Educational Background : Advanced degree (MS or PhD, or equivalent) in statistics or closely related fieldExperience : 4-6 years (or 3-5 years for PhD) direct advance knowledge of clinical trials design and analysis experience with advanced SAS programming experienceWorking knowledge of CDISC standards and application of those standards to projectsPersonal skills & behaviours : Ability to effectively communicate with others on the project team and in the department;
strong interpersonal communication skillsDetail oriented, well organizedAbility to work on several projects simultaneouslyDemonstrated knowledge of design of clinical trials and regulatory requirementsDemonstrated working knowledge of advanced SAS macro development and code generation / management algorithmsKnowledge of design of clinical trials and regulatory requirementsExcellent English communication skills (verbal, written & interpersonal)#LI-BL1