Manager, Biostatistics

Responsibilities:
- Provide statistical leadership for clinical development programs; ensure consistency/quality of statistical deliverables.
- Manage statistical activities for studies from program development through CSR creation/publication; collaborate with statisticians and statistical programmers.
- Serve as primary statistical point of contact for assigned programs/studies.
- Contribute to protocol development and study design.
- Perform sample size calculations; develop and/or review statistical analysis plans.
- Design and analyze clinical trials and real-world data (RCTs and observational studies) to support evidence generation.
- Collaborate cross-functionally (clinical development, medical affairs, clinical operations, data management, regulatory affairs).
- Review/approve internal and CRO statistical deliverables for quality and regulatory compliance.
- Manage biostatistics CRO partners to ensure SOP adherence.
- Partner with clinical/regulatory teams to identify statistical risks and mitigation strategies.
- Support regulatory interactions on statistical topics (meetings, responses to information requests, briefing materials).

Qualifications:
- Master’s degree in statistics/biostatistics.
- Minimum 2 years in biotech/pharmaceuticals.
- Experience in RCT design, analysis, and reporting.

Required/Preferred Skills:
- Strong clinical trial design knowledge (including adaptive designs).
- Communicate complex analyses to non-statisticians.
- CDISC and industry data standards.
- Regulatory guideline knowledge (regulatory support is a plus).
- SAS required; R is a plus.
- Real-world evidence/observational methods (causal inference) is a plus.
- Pain indication experience is a plus.

Benefits:
- Medical, dental, vision; FSA/HSA (company match); EAP; disability; life insurance; 401(k) with match; FTO/paid holidays; paid parental leave.