Senior Biostatistician

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.

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CRF is an equal opportunity employer.