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Remote Lead Clinical Statistician (Centralized Statistical Monitoring / Quality Tolerance Limits and Safety) (Science & Biotech)
HomeBased, NC 27713
Recruited by: Ali Henderson | Senior Recruiter | SimulStat Inc. See all my Jobs

  • Hiring Company: SimulStat's client
  • Industry: Science & Biotech
  • Compensation: Depends On Experience
  • Expires: Jul 05, 2019
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Job Description

remote, contract biostatistician, one year renewable contract with leading pharmaceutical company
Top 3 Must Have Skill Sets:
• Software Development Life Cycle experience
• 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
• Experience in assisting the safety team with aggregated analysis for signal detection for ongoing studies

Day to Day Responsibilities:
Within the first 30 days a successful placement will fully understand how client performs Centralized Statistical Monitoring (CSM) and able to perform the activities independently. Additionally, a successful placement will actively contribute to the development of Quality Tolerance Limits, including statistical methodology, utility development, and process development.
The Study Lead Statistician will be able to assist in developing standards which could lead the industry as client tries to meet Regulatory guidance related to safety monitoring. The work is industry-leading and will challenge the statistician to extend their technical skills to Safety surveillance.

Possible Extension:
Yes
Job Description

- Remote
- 1 year renewable contract
Study Lead Statistician – Centralized Statistical Monitoring / Quality Tolerance Limits and Safety

Basic Qualifications:

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
Strong skill 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
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
Excellent oral and written English communication skills
Strong fundamentals of Project Planning and Project Management
Demonstrated ability to immediately dive into detailed and/or complex projects
Strong SAS programming skills in applying statistical procedures based on complex study designs


Preferred Qualifications:

Master’s degree in Statistics/Biostatistics 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/Biostatistics or other subject with high statistical content and 5 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 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 such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings
Leadership of at least 3 clinical studies/projects with minimal oversight
Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
Software Development Life Cycle experience
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
Experience in assisting the safety team with aggregated analysis for signal detection for ongoing studies
Demonstrated ability to influence decision making
Development of policies and SOPs
Experience in adaptive clinical trials and innovative study designs
Experience in the utilization of Bayesian statistics in clinical trials


Experience

For Master’s degree: 3 years post-graduate experience in the pharmaceutical industry or medical research, 5+ years preferred
For Doctoral degree: 1 year post-graduate experience in the pharmaceutical industry or medical research, 2+ years preferred


Key Responsibilities:

Working as a member of the Centralized Statistical Monitoring (CSM) team you will be responsible for delivering CSM across multiple studies
Assist in the development of Quality Tolerance Limits (QTLs) including development of the Company’s policy and other controlled document
Provide statistical support to the safety team for safety signal detection
Design of new pragmatic algorithms for detection of clinical data quality potential issues
Review work performed by Study Statisticians and provide guidance to meet the study and project requirements
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
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


Potential Responsibilities:

Contribute to scientific advances in the field
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
Lead and/or participate in the development and review of Policies, SOPs and other controlled documents
May lead and/or participate in change / process improvement initiatives
Perform all duties and responsibilities associated with the Study Statistician role
Oversee the work performed by multiple Study Statisticians
May participate in external activities (e.g., Industry, academic)
May serve as a subject matter expert within a specified field of statistics internally and/or to external collaborators