Job Details
Summary
Our client, a leading med tech company with over 125 years of experience, has engaged GForce Life Sciences to provide a Sr. Biostatistician. This position will report to the Sr. Director of Biostatistics within the Biostatistics department. This individual will be responsible for collaborating with external partners handling delicate conversations to push a neurology initiative forward. This position requires the ability to work on solutions for analysis plans and have experience with pharmaceutical study designs.
Duties / Expectations of Role
- Responsible for consulting on the design of clinical trials and statistical analysis methodology for studies
- Recommend appropriate statistical methodology for the evaluation of analytical and clinical study data
- Interprets and evaluates test data and results of complex studies and develops appropriate recommendations
- Perform detailed review of clinical study protocols and development plans to ensure that the appropriate sample size and statistical methods are specified to support study endpoints
- Author statistical sections of protocols for development-phase projects
- Ensure that clinical monitoring plans, data management plans, and statistical analysis plans are harmonized and ensure delivery of high-quality data and analysis results for regulatory submissions
- Lead discussions and interacts with members of the Data Management and Clinical Affairs teams to align statistical endpoints of the clinical study to data collection, monitoring, and analysis activities
- Author Statistical Analysis Plans (SAP) for clinical studies, maintains plan through life cycle of study, and executes analyses per plan
- Develop statistical analysis programs to merge complex data structures from multiple databases, create analysis data set (ADS) and generate tables, listings, and figures (TLF) for reports
- Participate in development of database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations
- Ensure data specifications align with statistical analysis requirements and goals
- Provide complex specifications and directions to clinical data analysts for creation of ADS and/or TLFs
Mandatory Requirements
- Minimum educational background of MS in statistics/biostatistics or other quantitative field. Exceptional candidates with backgrounds bridging biological science and biostatistics will be considered
- At least 5 years of experience in biostatistics supporting development of medical diagnostics/devices and pharmaceutical
- Must demonstrate progressive experience in consulting and serving as lead consulting biostatistician on product development projects
- Proficiency in statistical programming (R) and query of relational database systems (SQL)
- Experience with extraction of data and reporting within Clinical Data Management systems (e.g. Medidata RAVE, Medrio, Oracle Clinical). Experience with Open Clinica preferred
- Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, survival analysis, and associated sample size calculations.
- Knowledge of diagnostic clinical trial statistics is required.
- Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solution to novel problems
- Familiar with FDA guidelines and CLSI guidelines applicable to medical diagnostics is a plus
- Experience with analysis of complex data from multiple source
- Ability to work independently and in project teams. Highly motivated and driven to exceed expectations
- Strong communication skills in English, written and spoken. Strong ability for public speaking in audiences with mixed backgrounds. Able to distill complex statistical concepts in simpler terms to generalized audiences
Term & Start
- Start Date: ASAP
- 12 Month+ Contract
- Remote
Benefits
- 401(k) matching
- Employer contributed competitive health benefits (medical, dental, vision)
- Philanthropy driven culture
- Consultant engagement social activities