DataCeutics is seeking top talent for positions within our Senior Statistics Department. If you are an experienced, passionate Statistician who has worked within a Pharma or CRO company within the Continental United States then we would love to hear from you. This is a full-time role. The applications will be considered from candidates who wish to work remotely anywhere from their home based anywhere in the Continental U.S.
Position Primary Function
The Senior Statistician performs high-level client consulting and develops and leads teams within DataCeutics and within clients’ departments. The Senior Statistician’s primary focus is to lead and perform the statistical planning and statistical analysis of clinical studies. The Senior Statistician’s responsibilities include the following:
Designing data acquisition trials, assessing results and analyzing trends;
Developing and reviewing Study Protocols and Statistical Analysis Plan;
Developing and executing study designs and regulatory strategy as related to drug development
Developing Integrated Safety Summary (ISS) and Integrated Efficacy Summary (ISE) Plans;
Orchestrating the analysis specifications through data analysis;
Implementing Table, Listing and Figure specifications;
Developing and implementing the Analysis Data Set Specifications;
Applying statistical methodology to complex data;
Developing, testing and running SAS programs for the statistical analysis and reporting of clinical study data. This includes programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings and their validation:
Writing the Statistical Section for a Clinical Study Report, ISS and ISE;
Using statistics to make forecasts and to provide projected figures;
Presenting information in a variety of formats;
Representing the client at regulatory agency meeting such as the FDA;
Routine Interfacing with client senior management;
Developing, publishing and presenting white papers and presentations at industry conferences;
Coordinating efficiently and effectively statistical activities for multiple projects simultaneously;
Serving as primary statistical representative for biometrics standalone projects or otherwise complex studies;
Effectively managing broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations;
Maintaining awareness of project budgets and tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate;
Providing guidance and work direction to junior employees.; and
Interacting with project team and managers to identify project priorities and communicate such activities and associated timelines to departmental management
Excellent management, interpersonal, communication, and organizational skills;
Ability and desire to interface with senior management and executives in client engagements and industry associations;
Ability to assess, analyze, develop and present statistics-based information to clients;
Recognized industry authority by clients and industry peers;
Master’s degree in Statistics required;
10 plus years Pharmaceutical or CRO industry experience;
Working knowledge of CDISC, SDTM and ADaM;
Experienced in developing, writing, publishing and presenting industry papers at conferences;
Experience with SAS statistical software;
Experience with regulatory submissions and support preferred;
Previous experience in a senior-level Statistician role;
Ability to maintain confidentiality of data and information during interactions with staff at all levels;
Extensive experience in leading statistical activities in clinical research;
Previous experience within a pharmaceutical research or CRO organization;
Ability to program in one or more statistical software packages used to conduct statistical analyses;
Proven ability to effectively communicate statistical concepts;
Candidates must be fluent in English language (both verbal and written)
MORE INFORMATION AVAILABLE ON REQUEST
To apply, please send your CV to firstname.lastname@example.org or apply using the form on this page.
Full Service or Project Based. For more information on DataCeutics please visit: www.dataceutics.com.
DataCeutics is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.
Customers’ requirements vary, from full-service support to very specific project work. In each situation, our skilled staff complete the task.
SALARY: On Application.
POSITION TYPE: Permanent, Full Time.