Senior Staff Biostatistician - Tarrytown, New York United States - 38879



JOB DESCRIPTION

Job #: 38879
Title: Senior Staff Biostatistician
Job Location: Tarrytown, New York - United States
Employment Type:
Salary: contact recruiter for details
Other Compensation: 15% bonus
Employer Will Recruit From: Nationwide
Relocation Paid?: Yes

WHY IS THIS A GREAT OPPORTUNITY?


Seeking a technical expert in biostatistics to lead statistical evaluations of analytical & clinical validation studies for new IVD devices being developed

Work on product development projects, training, develop reports, tech documentation, and procedures (on statistical methods)

Responsible for designing, planning, and executing statistical analyses of studies directed towards the development, verification, validation, and monitoring of products

Develops Statistical Analysis Plans (SAP) for clinical studies, maintains plan through life cycle of study, and executes analyses per plan.

Mentors statistical staff on statistical methodology and programming. Assists in departmental training of staff.

JOB DESCRIPTION

Senior Staff Biostatistician

Elmsford NY or Remote
Competitive Salary, Bonus, 6% 401K, 4 Weeks PTO, Excellent Benefits
 

We have a newly created opening for an experienced Senior Staff Biostatistician with a longstanding client; a multi-billion global medical diagnostics/instrumentation company. 

 

Keys to this position:

  • Seeking a technical expert in biostatistics to lead statistical evaluations of analytical & clinical validationn studies for new IVD devices being developed
  • Work on product development projects, training, develop reports, tech documentation, and procedures (on statistical methods)
  • High level team leadership across Clinical & Medical Affairs, Data Mgt, RA, and Global Assay Development
  • Responsible for designing, planning, and executing statistical analyses of studies directed towards the development, verification, validation, and monitoring of products
  • Develops Statistical Analysis Plans (SAP) for clinical studies, maintains plan through life cycle of study, and executes analyses per plan.
  • Mentors statistical staff on statistical methodology and programming. Assists in departmental training of staff.
  • Keeps abreast of new developments in statistics, industry development, and regulatory guidance through literature review and attendance at workshops and professional meetings.

QUALIFICATIONS

 QUALIFICATIONS

  • Masters  or PhD in Statistics/Biostatistics strongly preferred
  • 8-25+ years experience, with expertise in statistical and data analysis with medical diagnostics, medical devices, pharmaceutical, life sciences, or similar.
  • Must have min 3 yrs experience with R&D based, clinical trials.
  • Proficiency in statistical programming (SAS, R) and query of relational database systems (SQL). Certifications in SAS programming a plus.
  • Experience with extraction of data and reporting within Clinical Data Management systems (e.g. Medidata RAVE, Medrio, Oracle Clinical).
  • Knowledge of CDISC data standard models desired (CDASH, STDM, ADAM).
  • Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, sample size calculations.
  • Desired knowledge of statistical methodologies such as Quality by Design, Design Space, Experimental Designs, Regression.
  • Ability to work independently and in project teams - mentor & lead junior Statisticians
  • Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solution to novel problems.
  • Experience with analysis of complex data from multiple source.
  • Excellent communication skills (written and spoken). Strong ability to interact with others and to distill complex concepts in simpler terms to generalized audiences

Education:
University - Master's Degree

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