This role leads statistical programming activities across study or project levels ensuring adherence to company SOPs and ICH/GCP guidelines
Job Summary
This role leads statistical programming activities across study or project levels ensuring adherence to company SOPs and ICH/GCP guidelines.
The successful candidate will author CDISC ADaM specifications and define programming endpoint algorithms while managing electronic submission components.
Biogen offers a competitive compensation package including short-term and long-term incentives along with comprehensive benefits like tuition reimbursement and paid parental leave.
Matching Summary
This role leads statistical programming activities across study or project levels ensuring adherence to company SOPs and ICH/GCP guidelines.
Salary
Base: $141,000.00-$188,000.00; Bonus/Equity: Short-term cash bonus and equity incentive opportunities available; Benefits: Medical, Dental, Vision, Life, 401(k) match, Tuition reimbursement up to $10,000
Skills & Requirements
Must-have
10+ years SAS Base programming experience
7+ years SAS STAT GRAPH MACRO usage
CDISC standards and eSUB compliance
Clinical trial and database management expertise
Drug development process knowledge
Nice-to-have
ISS/ISE and NDA/BLA submission experience
PKPD and biomarker analysis background
Passion for analytics and data-driven decisions
Collaborative learning mindset
Process improvement initiative leadership
Key Requirements
Bachelor's degree required; Masters or PhD preferred
10+ years relevant industry and clinical trial experience
5+ years clinical database experience
Extensive knowledge of FDA/EMEA/ROW submission guidelines