: Study Lead Statistician – Centralized Statistical Monitoring (CSM) (JP7217)
Thousand Oaks, CA
Design & Innovation
: 12 months with likely extensions
Job posting date
3 Key Consulting is hiring a Study Lead Statistician for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
***Remote working possible if experienced****
The Study Lead Statistician for Centralized Statistical Monitoring (CSM) will assist in the development of methodologies that will result in the development of software to aid in the evaluation of the integrity of clinical trial data. Working as a member of the Centralized Statistical Monitoring (CSM) team you will be responsible for delivering and enhancing CSM across multiple studies.
Basic Job Responsibilities
- Design of new pragmatic algorithms for detection of clinical data quality issues.
- Assist in support of Software Development Life Cycle.
- Working as a member of the cross-functional Centralized Statistical Monitoring (CSM) team you will be responsible for delivering CSM across multiple studies.
- Assist in resource planning for assigned projects.
- Be familiar with all Company’s policies, SOPs and other controlled documents related to all study activities performed.
- Be familiar with statistical policy and strategy at the company.
- Assist with study and systems audits conducted by Company GCA and external bodies.
- Stay abreast of latest developments in the field of statistics in drug development and centralized statistical monitoring.
- Contribute to scientific advances in the field within the company.
- Promote and communicate statistical awareness and the role of the Global Biostatistics department, and may contribute to statistical consultancy, statistical training and expert advice within Global Biostatistics and within the company.
- Lead and/or participate in change / process improvement initiatives within the company.
- Perform all duties and responsibilities associated with the Study Lead Statistician role.
- Oversee the work performed by multiple Study Statisticians.
- Participate in external activities (e.g., Industry, academic).
- Serve as a subject matter expert within a specified field of statistics internally and/or to external collaborators.
- ****Strong SAS programming skills****
- Master’s degree in Statistics/Biostatistics or other subject with high statistical content with at least 3 years of post-graduate statistical experience in the pharmaceutical industry or medical research OR Doctoral degree in Statistics/Biostatistics or other subject with high statistical content and 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research.
- Strong skills in communicating statistical information clearly and concisely (written and oral).
- Strong understanding of statistical concepts related to the design and conduct of clinical Studies.
- Strong ability to apply statistics in the analysis of clinical trials (deriving, analyzing, visualizing, interpreting).
- Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia.
- Software Development Life Cycle experience.
- Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions, that include programming teams.
- Excellent oral and written English communication skills.
- Strong fundamentals of Project Planning and Project Management.
- Master’s degree in Statistics/Bio-statistics or other subject with high statistical content and at least 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research OR Doctoral degree in Statistics/Bio-statistics or other subject with high statistical content and 3 years of post-graduate statistical experience in the pharmaceutical industry or medical research.
- Designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/ Public Health setting in Industry, Government or Academia.
- Authored a protocol, DRT/DMC charter, SAP and/or CSR.
- Demonstrated ability in presenting results and defending statistical findings, study design and analysis to internal audiences (study/product team) AND at external meetings.
- Development of policies and SOPs.
- Experience in the utilization of Bayesian statistics in clinical trials.
Top Must have Skill Sets:
- Software Development Life Cycle experience (defining, designing, testing, development maintenance).
- Strong ability to apply statistics in the analysis of clinical trials / phase trials (deriving, analyzing, visualizing, interpreting).
- 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.
Within the first 30 days a successful placement will fully understand how the company 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 the company 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).
Lack of hands on statistical analysis experience.
Lack of software development experience.
Phone interviews starting week of April 27th
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
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