Biostatistician

About the role

The Statistical Sciences Contractor will support the execution of the PULSEcheck (Progressive Uptake of Live Scientific Evaluation) initiative by partnering with study teams to monitor ongoing clinical trials and generate timely, data-driven insights. This role will focus on reviewing accumulating clinical trial data, evaluating predefined PULSEcheck criteria, conducting exploratory analyses, and supporting informed decision-making throughout study execution.

The contractor will work closely with study statisticians, programmers, and cross-functional stakeholders to assess study progress, identify emerging trends and risks, and provide analytical support that enhances trial oversight while maintaining scientific rigor. Responsible for overseeing all aspects of statistical planning and analyses for clinical programs; directs both internal and external SAS programming efforts related to the responsible clinical programs.

Responsibilities

• Review accumulating clinical trial data and evaluate predefined PULSEcheck criteria.
• Conduct exploratory analyses and interim analyses to support data monitoring activities.
• Translate complex datasets into actionable insights for study teams.
• Oversee statistical planning and analyses for clinical programs.
• Direct internal and external SAS programming efforts related to clinical programs.
• Collaborate with cross-functional stakeholders to assess study progress and identify risks.

Qualifications

• Master's degree or PhD in Statistics, Biostatistics, Data Science, Mathematics, Epidemiology, or a related quantitative field.
• 5 to 7 years of experience in the pharmaceutical or biotechnology industry.
• Experience preparing analysis programs for clinical trials (phases I-III).
• Primary statistician on at least one NDA/BLA.
• Sound knowledge of statistical applications for clinical trials.
• Strong understanding of statistical methodologies and clinical trial data analysis.
• Strong knowledge of and experience in clinical trial design.
• Very good knowledge of drug development regulations pertinent to trial design and statistical analysis.

Skills

• Statistical programming in R (SAS experience is a plus).
• Excellent writing and communication skills.
• Ability to conduct exploratory and interim analyses.

Benefits

• Healthcare Insurance: Eligible employees and their dependents receive healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment. Premiums are subsidized by Synectics.
• Dental Insurance: Eligible employees and their dependents receive a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
• Vision Insurance: Eligible employees receive vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
• 401(k) Plan: Synectics offers all employees aged 21 or older the opportunity to invest in the 401(k) Plan on the first of the month following at least one calendar year of employment.