Associate Director, Safety Statistician

Job Title: Associate Director, Safety Statistician
Location: REMOTE – Must be based in EST or CST time zones only (with occasional travel to NJ)
Type: Direct Hire with sponsor client
Target Base Compensation: $180k-190k salary (dependent on experience; might have flex for higher salary if exceeding requirements)
Annual bonus, RSUs, 401k match, PTO/Personal/Sick time and a comprehensive health benefits package.

Minimum Requirements:

• PhD in Statistics or Biostatistics
• 2+ years Oncology Safety Signal experience as a Statistician
• Recent Oncology experience Phase II-III
• Prior leadership experience

Job Summary:
Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and statistical aspects for safety signal detection and characterization for ongoing studies and compound-level pooled clinical trial data of project(s). Act as a statistical expert consultant within the company for safety analyses.

Responsibilities:

• Lead for safety signal statistical handling, lead the statistical support in safety signal detection, validation, characterization, and reporting in collaboration with the safety programming team, CSPV, and epidemiology for several projects with minimal direction from the group head, and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety signal monitoring for ongoing trials.
• Safety analysis methodology and standardization, develop and support statistical safety analysis methodology and standardization across the clinical development in cross-functional teams.
• Builds partnerships with safety programming teams, project statistical teams, and internal cross-functional teams and external institutions to maximize available resources.
• Safety working groups and initiatives represent statistics to participate (and lead if applicable) in safety signal working groups or cross-functional initiatives.

Education:

• PhD In statistics or Biostatistics required

Experience:

• Minimum 5 years of relevant experience in the pharmaceutical industry and experience as a safety statistician required.

Travel:

• 10%

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M-
#LI-
#DI-

Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.