Job Description

This role is subject to a flexible hybrid work arrangement requiring a minimum of 1-2 pre-determined days per week in our mid-town office.

SUMMARY

As a member of clinical trial teams, the Senior Statistician brings statistical expertise to the design, conduct, analysis and reporting of clinical studies, in the pre-clinical, Phases I to IV, and post-marketing, stages of study. The Senior Statistician works as a member of cross-functional teams and continuously strives to ensure timely delivery and scientific validity of results. He/she will work closely with statistical team and company programmers to ensure a seamless, accurate and timely delivery of scientific data reporting of study trials and activities sponsored or conducted by company.

The Senior Biostatistician supports physicians/ principal investigators in all academic/ sponsor-driven quantitative analysis which includes: Producing statistical analysis plans, creating table-shells, contributing to written manuscripts and research articles, and participating on clinical safety boards. In addition, we expect a high level of creative statistical thinking and theoretical knowledge from the Senior Biostatistician.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Design, analyze, and report on new/continuing sponsor-related clinical trials
• Review and prepare statistical sections of study protocols and perform sample size calculations
• Review and prepare detailed statistical analysis plans and table/listing/graph shells
• Work with a multifunctional team of SAS programmers, data managers, and physicians in reviewing case report forms, identifying data quality issues, and producing analysis datasets and data outputs
• Validate statistical analyses to ensure data accuracy in final clinical study reports and provide statistical interpretations of results
• Interface with project management, functional team members and investigators to ensure a timely, precise and accurate clinical data reporting process
• Interact with medical directors/writers to ensure appropriateness of data inferences; draft pertinent sections of a clinical trial report or statistical report
• Use SAS software (knowledge of more programming languages desired)
• Collaborate with Cardiovascular Physicians on academic research
• Participate in Data Safety Monitoring Boards
• Represent the Biostatistics group in regulatory agency and project team meetings

QUALIFICATIONS

• Possess a PhD degree in Biostatistics or Statistics, preferably experience in clinical trials
• Application experience in cardiology and/or prior experience in medical device clinical trials is a plus
• Proficiency in SAS programming
• Experience in authoring manuscripts, clinical documents and templates
• Structure research hypotheses with sound analysis
• Understand the clinical trial process, and the statistician's role.

BENEFITS

• Choice of health plans include medical, Dental, and vision coverage
• Company-paid short-term and long-term disability and life insurance
• Health and dependent care flexible spending accounts
• Pre-tax travel expenses through TransitChek program
• 401(k) plan
• Generous paid time off (PTO)
• Ten paid holidays each year

COMPENSATION
The hiring range for this position is $105,000 - $115,000 per year. The annual salary that will ultimately be offered to the successful candidate will depend on job-related knowledge, education, skills, and experience.

CONTACT INFORMATION

To be considered for this opportunity, please submit your resume.

Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day

CRF is an equal opportunity employer.

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Job Tags

Holiday work, Full time, Temporary work, Flexible hours, 2 days per week, 1 day per week,

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