Posted in Research 30+ days ago.
Type: Full Time
The Director of Biostatistics in Immunology provides direction and oversight on clinical development plans, protocols and analysis, reviews clinical study reports and regulatory submission materials, and ensures the adherence to standard procedures . He/she also provides direct contributions as appropriate to complex statistical analysis plans and interim analysis approaches to gain alignment across organization. The Director builds and maintains strong collaboration with key stakeholders from different disciplines across the organization to facilitate agile and robust clinical development plans and decision framework. He/She interacts with head of statistical programming and data management to synchronize prioritization of projects and in some cases, he/she represents Biostatistics in meetings with executive committee, R&D governance committee, regulatory agencies, advisory boards and external development partners as appropriate.
The Director of Biostatistics provides mentorship to biostatisticians in the department and facilitates consistent statistical approaches across teams and locations. He/She also provides leadership for the department in achieving visions and goals, including driving process improvement initiatives and enhancement of technical capabilities of the department.
Directs overall statistical activities for the projects assigned including implementing efficient, consistent, and practical processes for Biostatistics and develops, implements and monitors resource allocation and usage for assigned projects
Provides guidance and direct input into strategy, planning and contents of clinical development plan as well as key components of regulatory submissions. Strives to increase the scientific agility by facilitating the implementation of innovative approaches and increase operational efficiency by close monitoring of the operating procedures and strategies for Biostatistics. Serves as the primary functional reviewer of protocols, analysis plans, and clinical study reports
Provides guidance and support for all biostatisticians in assigned projects; develops staff through coaching and training. Provides broader mentoring and guidance to ensure that the Biostatistics/ADS missions and goals are achieved.
Provides guidance and direct input in addressing and statistical issues from regulatory, legal or other challenges to the company's products or processes and represents the biostatistics of the company in key regulatory meetings or meetings with KOLs
Participates in and/or leads cross-functional initiatives representing ADS. Participates in key R&D governance meetings and may represent Biostatistics or ADS as appropriate#LI-TG1
PhD in Biostatistics/Statistics or equivalent with a minimum of 9-10 years relevant work experience or MS in Biostatistics/Statistics with a minimum of 11-12 years relevant experience
Substantial past regulatory experiences, including interactions with FDA, EMA, and PMDA and BLA/NDA/MAA submission experiences.
Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them
Ability to develop innovative/creative statistical/technical solutions to complex problems
Knowledge and experienced in meeting regulatory guidance, both FDA and international regulatory agencies
Broad knowledge of medical/biological terminology and clinical trial design in relevant therapeutic areas
Strong verbal and written communication skills. able to explain methodology and consequences of decisions in lay terms
Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflicts resolutions, and effective partnership
Strong people manager with track record of staff development
The Director of Biostatistics in Immunology is accountable for all biostatistics activities and deliverables for late development phase including systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE) and providing direct supervision for one or more project leader(s).