Associate Director Biostatistics Job in Lexington 02421, Massachusetts US
Primary Role
Responsible for assisting the Director, Biostatistics with managing the Biostatistics Group and for leading all biostatistics-related activities within selected therapeutic areas through direct product responsibility or through subordinates.
Responsibilities
Responsible for statistical leadership on project teams and for assisting the Director, Biostatistics with management of the Biostatistics group.
Participates in hiring and in planning and assigning work; manages Biostatistics staff, as needed; sets objectives and creates development plans, appraises performance, provides performance-related feedback, and rewards and recognizes employees.
Collaborates with project teams on the design and analysis of clinical trials; selects appropriate statistical methods for the design of clinical trials and the analysis of clinical study data; provides input into clinical development plans; when needed, approves protocols, statistical analysis plans (SAPs), and clinical study reports (CSRs) as designee of the Director of Biostatistics.
Serves as leader of large projects or as therapeutic area leader within biostatistics for selected programs; collaborates with project and product strategy teams; communicates therapeutic area plans and strategy to the Biometrics leadership team and other members of the Biometrics group, including subordinates, as needed.
Collaborates with the Medical Writer and Physician on the interpretation of efficacy results.
Reviews regulatory documents, such as CSRs, as well as summary documents.
Interacts with FDA personnel on statistical issues in the design and analysis of clinical trials and regarding data presentations.
Contributes to the publication plan. Reviews abstracts, posters, and manuscripts to support Medical Affairs.
Leads or contributes to departmental process improvement initiatives and development and revision of SOPs.
Leads or contributes to the establishment and maintenance of standards and templates for key Biometrics deliverables (eg statistical section of protocol, SAPs, and Tables, Figures and Listings).
Identifies the need for contractors and supervises contractors to support projects. Directs outsourcing activities in collaboration with preferred vendors.
Education and Experience Requirements
• M.S. in Biostatistics or closely related field is required.
• Ph.D. in Biostatistics or closely related field is preferred.
• Generally has 8+ years of relevant pharmaceutical experience
Key Skills, Abilities and Competencies
• Extensive experience in the design, analysis, and reporting of clinical trials in the regulatory environment with good background and knowledge of statistical methods across all phases of clinical trials.
• Proven statistical leadership. Management experience is strongly preferred.
• Ability to understand the broader business and organizational context and to collaborate in planning efforts across departments or organizational boundaries to ensure organizational effectiveness.
• Experience in developing statistical analysis plans, including the shells for tables, figures, and data listings.
• Working knowledge of relevant regulatory guidances (e.g. ICH, FDA, and EMEA).
• Direct regulatory filing experience is preferred.
• Proficiency in SAS is required.
Complexity and Problem Solving
Ability to determine appropriate designs and analyses for clinical trials.
Ability to respond to regulator's inquiries for products undergoing registration and approved products.
Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed.
Internal and External Contacts
Physicians, Clinical Leaders, Regulatory Therapy Area Leaders, Data Managers, Statistical Programmers, Clinical Pharmacologists, Medical Affairs personnel, Medical Writers, Regulatory Publishing staff, Business Unit representatives, Program Managers, CROs, consultants, and academics.
Other Job Requirements
Some domestic and international travel required.
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Shire is an Equal Opportunity and Affirmative Action Employer
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