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 position provides expertise and leadership for regulatory submissions and product life-cycle management strategy planning and implementation. It leads statistical design, analysis, and reporting for clinical and other scientific research programs; independently develops protocols and statistical analysis plans; and represents Statistics on project teams. The Associate Director partners with Clinical, Regulatory, Patient Safety, and Global Medical Affairs teams to develop strategies for assigned projects. The role applies extensive statistical knowledge, proposes methodological approaches, specifies analyses in sufficient detail for programming, and ensures analyses are conducted appropriately. It develops data-presentation and inference strategies, supports interpretation of statistical deliverables, contributes to scientific publications, and ensures reports and publications are accurate and internally consistent. The Associate Director trains and mentors staff, may supervise contract or junior statisticians, supports recruitment and professional development, and builds external scientific connections. The role also serves as a statistical liaison with external collaborators, ensures regulatory requirements are met, critically reviews submission documents, participates in regulatory discussions as needed, and validates external statistical software for compliance with SOPs and regulatory requirements.
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 provide solutions using own skills and knowledge 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 strong performance.
- Motivation to drive innovation by raising standards and challenging the status quo.
Nice To Haves
- Experience with late-stage clinical trials and/or 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 safety or Global Medical Affairs evidence-generation analysis plans as applicable.
- Represent the Statistics function on project teams, provide statistical input to compound or drug development, and drive alignment with functional management.
- Partner with Clinical, Regulatory, Patient Safety, and Global Medical Affairs teams to create development strategies for assigned projects.
- Propose statistical methodological approaches for scientific study design 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; may supervise contract statisticians or junior statisticians.
- Assist functional leaders with recruiting qualified personnel and arranging professional development training.
- Develop strategies for data presentation and inference and ensure appropriate interpretation of statistical deliverables with other functions.
- Collaborate on scientific publications and ensure reports and publications, including tables, listings, and figures, are accurate and internally consistent.
- Liaise on statistical issues 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 applicable regulatory requirements for work processes are met, 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 leave.
- 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
