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Study Lead Statistician Centralized Statistical Monitoring (CSM
US-CA-Newbury Park
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***please submit at open market rate***

The Study Lead Statistician / Data Analyst - Centralized Statistical Monitoring (CSM) will work as a key member of the Centralized Statistical Monitoring (CSM) team.

The ideal candidate will build machine learning and other statistical models, as well as support their implementation and deployment through a good understanding of the Software Development Life Cycle (SDLC). Develop business requirements thru collaborations with cross-functional stakeholders and the use of excellent communication skills.
Functional requirements, prototype code, good documentation, testing, and relevant visualizations will be expected as deliverables when producing new algorithms as required by the stakeholders. Excellent programming skills required.
Experience with clinical trials and its data collection process, storage, and quality, are highly desirable.

The ideal candidate must enjoy the challenge of analyzing disparate data, and program innovative ways to approach it. They must possess good handling of a wide variety of tools to tackle these challenges while exhibiting creativity as well as analytical rigor in so doing. Excellent organization skills will be needed. These will be important when managing information, data sources, and/or user documentation. This person will be able to adapt and abide by controlled processes (SOPs), as they will be working under regulatory requirements from official sources. The candidate must be self-motivated, independent, a fast learner, and demonstrate good time-management skills. Good reporting skills are a plus. Preparation of reports and presentations will be part of their job.

Responsibilities will include among others:

Ability to perform data analysis in a wide range of data and analytics solutions, from descriptive to predictive, using advanced statistical and machine learning models
Leverage large data sets to conduct end-to end analytics that will include data gathering, requirements specifications, processing, analytics, ongoing deliverables, and presentations
Interact cross-functionally with a wide variety of people and teams. Work closely with subject matter experts to deliver value by developing novel, practical, scientific data-driven solutions to meet business needs

PhD in Statistics or in a related subject with substantial statistical knowledge
Master's degree in Statistics or in a related subject & 2+ years of directly related experience
Bachelor's degree in Statistics or in a related subject & 4+ years of directly related experience

Preferred Qualifications:
Experience working with large data sets, data mining, and machine learning tools
A good understanding of clinical data
Experience working in a software development environment
Experience constructing data visualizations of clinical data
Experience with SAS programming and/or R
Understanding of Clinical Trials
Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy
Independent, self-motivated, organized, able to multi-task in time-sensitive environments, and skilled in communication, facilitation, and collaboration
Familiarity with DevOps and software best practices (i.e., version control, continuous integration, test driven development)
Excellent communication skills (written and verbal)

***Remote working possible if experienced***
Top 3 Must Have Skill Sets:
o Software Development Life Cycle experience (defining, designing, testing, development maintenance)
o Strong ability to apply statistics in the analysis of clinical trials / phase trials(deriving, analyzing, visualizing, interpreting)
o Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions, working with clinical development colleagues in study management, programming and IS
Day to Day Responsibilities:
Within the first 30 days a successful placement will fully understand how Our Client performs Centralized Statistical Monitoring (CSM) and able to perform the activities independently.
Employee Value Proposition:
The Study Lead Statistician will be able to assist in developing standards which could lead the industry as Our Client further grows Centralized Statistical Monitoring. There are 2 main teams, meeting weekly - group of type A and external service providers, having statistical discussions within groups - weekly cross functional team meeting (more a broader group, development IS team and programming team, standard program support team, study managers) (16 people)
Possible Extension:
Red Flags:
Lack of hands on statistical analysis experience --
Lack of software development experience
jumpy resumes
Interview Process:


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