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25 days old

Statistician II (Clinical Studies), Princeton, New Jersey

Kelly Services
Princeton, NJ 08544
  • Jobs Rated
    2nd
**Statistician II (Clinical Studies), Princeton, New Jersey**



**Direct Hire**




+ **Responsible for leading projects across multiple studies or programs** .

+ P **rimary contact with the sponsor for all biostatistics related activities on assigned projects** .



**RESPONSIBILITIES:**




+ Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates.

+ Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel.

+ Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.

+ Provides independent review of project work produced by other biostatisticians in the department.

+ Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.

+ Prepares or oversees the preparation of Statistical Analysis Plans SAPs , including development of well-presented mock-up displays for tables, listings, and figures.

+ Collaborates with sponsor, if required.

+ May be responsible as Lead Biostatician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.

+ Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.

+ Reviews SAS annotated case report forms CRFs, database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.

+ Implements company objectives and creates alternative solutions to address business and operational challenges.

+ As biostatistics representative on project teams, interfaces with other departmental project team representatives

+ Preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.

+ Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications.

+ May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.

+ Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.

+ Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management.

+ Provides statistical programming support as needed.

+ May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. May serve as a voting statistician on DSMBs and/or DMCs.

+ Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).

+ Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.

+ Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.

+ Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others

+ Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.

+ Performs other work-related duties as assigned.

+ Minimal travel may be required.





**QUALIFICATION REQUIREMENTS**




+ Graduate degree in biostatistics or related discipline.

+ Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies.

+ Years of experience required: 8-12 years of related, progressive experience preferred

+ Proficiency in programming.

+ Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.

+ Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.

+ Experience with regulatory submissions preferred.

+ Excellent written and verbal communication skills.

+ Ability to read, write, speak, and understand English.








**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Jobs Rated Reports for Statistician

Posted: 2020-11-04 Expires: 2020-12-12

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Statistician II (Clinical Studies), Princeton, New Jersey

Kelly Services
Princeton, NJ 08544

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Statistician
2nd2019 - Statistician
Overall Rating: 2/199
Median Salary: $84,760

Work Environment
Very Good
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Stress
Very Low
43/220
Growth
Very Good
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