The Associate Director is responsible for assisting the Director, Statistics with management and leadership of biostatistics-related activities within Rare Diseases therapeutic area through direct product responsibility. Contributes to product development strategy and serves as a statistical expert in registration and communication activities. Represents Takeda and provides input to his/her supervisor for statistical issues in communications with regulatory authorities. Reviews regulatory documents such as protocols and Clinical Study Reports, as well as summary documents.
Provides leadership in biometrics activities pertaining to study projects. Collaborates with project teams on design and analysis of clinical trials; selects appropriate statistical methods for design of clinical trials and the analysis of clinical study data; provides input into clinical development plans.
Provides specification and reviews draft randomization schedules. Primary SAP author/reviewer. Determines and provides appropriate sample size calculations for specific objectives of study design.
Reviews statistical outputs. Primary author of the statistical methodology section(s) of study reports for study and integrated reports.
Responsible for interacting with regulatory authority personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations.
Reviews regulatory documents such as CSRs, as well as summary documents.
Consults with the Medical Writer and Physician on the interpretation of efficacy results.Contributes to the publication plan. Reviews abstracts, posters, and manuscripts to support Medical Affairs.
Leads or contributes to departmental process improvement initiatives and development/revision of SOPs.
Contributes to the establishment and maintenance of common formats and templates for key Biometrics documentation (e.g., statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings). Contributes to the design of standards for SAPs.
Directs outsourcing activities in collaboration with preferred vendors. Provides strategic and tactical input in the contracting with Statistical & Quantitative Sciences (SQS) preferred providers.
Education and Experience Requirements
M.S. in Biostatistics or closely related field is required.
Ph.D. in Biostatistics or closely related field is strongly preferred.
Generally has 8+ years of relevant pharmaceutical experience.
Key Skills, Abilities, and Competencies
Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs. Must have a working knowledge of statistical analysis plans including the report outline, mockup tables, graphs and data listing shells and appendices.
Must have a working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA).
Direct regulatory filing experience is required.
Proficiency in SAS is strongly preferred.
Ability to help others understand the broader business and organizational context (inspiring and motivating others)
Demonstrated ability to deliver excellence by integrating planning efforts across departments or organizational boundaries to ensure organizational effectiveness (delivering excellence)
Demonstrates a customer focus by partnering with customers as a trusted consultant and serves as an integral part of customer’s decision-making process (serving customers)
Demonstrated ability to reinforce a culture in which partnering is a norm (global and cross-boundary communication)
Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership)
Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making)
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.
Medical Surveillance & Risk Management group, Statistical experts, External partners and companies, vendors, data monitor committees