Job Description

Employer Industry: Pharmaceutical Company

Why consider this job opportunity:

• Salary up to $245,985.00, plus incentive opportunities
• Comprehensive benefits package including medical, dental, vision, and prescription drug coverage
• Generous 401(k) match and tuition reimbursement programs
• Flexible time off and paid leave programs
• Opportunity for career advancement and professional development
• Hybrid work policy with the possibility of remote arrangements

What to Expect (Job Responsibilities):

• Provide statistical analysis plans, including study design and statistical methods in protocol development
• Collaborate with core study/project teams to provide statistical input during clinical trial conduct
• Develop Statistical Analysis Plans (SAP) and mock TFLs for analyses
• Participate in strategic planning for regulatory interactions and prepare documentation for FDA meetings
• Lead biostatistical tasks for designated therapeutic areas and manage supporting statisticians

What is Required (Qualifications):

• PhD or Masters degree in Statistics or Biostatistics
• Minimum of 7 years (PhD) or 9 years (Masters) of experience in the pharmaceutical industry
• Strong knowledge of U.S. regulatory requirements and NDA preparation for submissions
• In-depth knowledge of statistical principles and SAS/R programming software
• Effective communication skills with stakeholders across various functional areas

How to Stand Out (Preferred Qualifications):

• Experience in the CNS area is a plus
• Familiarity with regulatory submission processes in both the U.S. and EU
• Demonstrated ability to influence and communicate effectively at all levels

We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.

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