Associate Director, Statistics - Immunology (Hybrid)
About The Position
The Associate Director, Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Work may include clinical trials, patient safety, and global medical affairs. The role partners with experts across multiple disciplines to advance medicines to patients. The Associate Director leads statistical strategy and execution for regulatory submissions, product life-cycle management, and scientific research programs. This includes designing, analyzing, and reporting studies; developing protocols and statistical analysis plans; ensuring appropriate analysis implementation and interpretation; and contributing to regulatory documents and interactions. The position also provides mentorship and training to staff, collaborates with internal and external partners, supports scientific publications, and ensures statistical work complies with applicable regulatory requirements and company procedures.
Requirements
- MS in Statistics, Biostatistics, or a highly related field with 10 or more years of experience, or PhD in one of these fields with 6 or more years of experience.
- Strong leadership skills and experience working with or managing cross-cultural or overseas teams.
- Pharmaceutical knowledge, including experience and understanding of drug development and life-cycle management in a regulated environment.
- High degree of technical competence and excellent oral and written communication skills.
- Ability to identify data or analytical issues and help develop solutions using personal expertise or by seeking assistance.
- Ability to manage project timelines and the quality of deliverables.
- Ability to build strong relationships with peers and cross-functional partners to achieve high performance.
- Motivation to drive innovation by raising standards and challenging the status quo.
Nice To Haves
- Experience with late-stage clinical trials and/or regulatory submissions.
- Experience with immunology clinical trials.
Responsibilities
- Lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects.
- Provide statistical leadership for the design, analysis, and reporting of clinical or other scientific research programs.
- Independently develop protocols and statistical analysis plans, including product safety, integrated safety, and global medical affairs evidence-generation plans as applicable.
- Represent Statistics on project teams, provide statistical input to compound or drug development, and align with functional management.
- Partner with Clinical, Regulatory, Patient Safety, and Global Medical Affairs teams to create development strategies.
- Apply and explain statistical concepts and methods; propose novel methodological approaches and provide sufficient detail for programming implementation.
- Ensure statistical analyses specified in protocols and analysis plans are conducted appropriately.
- Train and mentor staff on statistical methodology and operations; potentially supervise contract or junior statisticians.
- Build expertise in innovative statistical methods and assist functional leaders with recruiting and professional development opportunities.
- Develop strategies for data presentation and inference, and ensure appropriate interpretation of statistical deliverables with other functions.
- Collaborate on scientific publications and ensure the accuracy and internal consistency of reports and publications, including tables, listings, and figures.
- Act as the statistical liaison for collaborative studies with CROs, academic institutions, government agencies, committees, joint ventures, and licensing collaborators.
- Build external scientific connections that support professional development and promote the Statistics department.
- Ensure work processes meet applicable regulatory requirements, critically review submission documents, and participate in regulatory agency discussions as needed.
- Validate external statistical software for compliance with SOPs and regulatory requirements.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
