Provides statistical input in the clinical development plan and protocols and conducts statistical analyses and summary of clinical studies and integrated database to help advance the drug development process.
This is a strategic and critical role in effectively and efficiently developing the process for approval of drug products.
60% - Protocol development
- Provides statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis method.
- Reviews protocol outlines and protocols.
- Produces randomization codes.
- Reviews CRF.
- Reviews and approves database structure and edit-check specifications.
- Reviews and approves other clinical documents, such as clinical operation manual, investigator brochure (I), etc.
- Develops final tables and listings (and figures) for final study report (FSR).
- Develops Table of Contents (TOC) and Tables & Listings templates.
- Develops a detailed Statistical Analysis Plan (SAP) to document technical considerations.
- Provides specs to SAS programmers for generating analysis datasets.
- Programs efficacy analysis and produces final efficacy tables and figures.
- Reviews final tables, listings, and figures.
- Develops tables and listings (and figures) for other regulatory submissions.
- Performs statistical analyses for PK/PD parameters.
- Provides safety tables and listings for IND annual reports and PSUR.
- Provides tables and listings for FDA meeting briefing packages.
- Performs exploratory analyses.
- Performs statistical analyses for marketing and Phase IV studies.
- Performs statistical analyses for abstracts, posters and publications.
- Develops final study report (FSR).
- Provides Statistical Methods section.
- Summarizes Efficacy Results.
- Reviews FSR.
- Handles FDA or other regulatory agencies' contracts and regulatory meetings.
- Drafts response to questions from regulatory agencies.
- Participates in preparing FDA briefing packages.
- Attends meetings with Regulatory Agencies.
- Interfaces with FDA statistical reviewers and serves on the rapid response team to address inquiries during the NDA review.
- NDA submissions
- Provides Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety ISS) tables.
- Reviews ISS and ISE reports.
- Prepares briefing packages for FDA Advisory Meetings.
- Participates in responding to Advisory Committee questions in NDA defense. 40%
- Provides statistical inputs on Clinical Development Plan regarding primary efficacy end point, go/no-go decision criteria, size of studies, and statistical methodologies.
- Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development.
- Reviews clinical, statistical, and regulatory literature for current clinical trial results, regulatory trends and new statistical methods to be applied on his/her assigned therapeutic area.
- Represents clients (internal OPDC, OFRI, OPJ-C, and external partners) at FDA meetings, FDA advisory boards, or other scientific meetings.
- Evaluates new statistical methodologies and AI/Machine Learning software and their potential applications in our clinical trial design and analysis as well as HEOR, RWD/RWE insight and analytics.
- Serves as the Biometrics project team leader regarding the statistical analysis, tables and listings, data collection and quality, and overall timeline.
- Assists in departmental planning and resource allocation and mentoring staff. Provides support for administrative duties as needed to the Senior Director.
- Assists in proposal development, FTE allocation, budget projections, and corporate presentations.
- Provides technical supervision over other biostatisticians assigned to his/her therapeutic area and assigns them the statistical tasks.
- Takes full responsibility in managing biostatistical tasks (as listed below) for one therapeutic area and provides strategic technical support to other clinical projects.
- Provides technical direction to supporting statisticians working on projects on a day-to-day basis.
Education & Experience
- PhD in Statistics or Biostatistics.
- Minimum 10 years of experience in the pharmaceutical industry.
- Understands the company's products, the competition, and the pharmaceutical industry in general.
- Demonstrates a competent knowledge of the company's work tools, processes, and policies.
- Maintains a current awareness of new drug developments and statistical methodologies in the business.
- Requires a strong working knowledge of applicable U.S. regulatory requirements and NDA preparation for submissions.
- In-depth knowledge of statistical principles, applications, and SAS/R programming software.
- Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
- Knows how/when to apply organizational policy or procedures to a variety of situations.
- Adaptable - Adjusts readily and effectively to frequent changes in the work, processes, and requirements of the position; tries to understand change and quickly adjust focus and behavior; able to adjust to new leadership, new ways of doing things, and new priorities.
- Building effective partnerships and work relationships - Uses appropriate interpersonal styles and communication methods to build and support effective working relationships with internal groups, global affiliates, and external groups; cultivates an active network; establishes and/or supports shared goals; reduces barriers between people, units, and/or locations; fosters open dialogue and effective communications; negotiates for an acceptable outcome.
- Strong oral and written communication and presentation skills - Clearly conveys information and ideas to individuals and groups (internal and external); makes it a point to communicate regularly to peers, team members, subordinates, and/or managers; effectively organizes information; maintains and adjusts to audience; ensures understanding; comprehends communication from others; provides clear and effective training to internal and external groups.
- Continuous learning - Makes specific efforts to improve and expand technical knowledge and skills; identifies new areas for learning; regularly creates and takes advantage of learning opportunities; uses newly gained knowledge and skills on the job; takes initiative to discover information about industry regulations and standards.
- Strong decision making and judgment - Identifies and understands issues, problems, and opportunities; compares data from different sources to draw conclusions and uses effective approaches for choosing a course of action or developing appropriate solutions; exercises appropriate judgment and involves others to obtain information; considers potential risks and makes the most appropriate decisions; communicates with all appropriate parties and ensures understanding of the resulting decisions.
- Driving for results with quality - Consistently produces quality results; completes tasks and projects requiring a great attention to detail; appropriately balances the need to meet deadlines with the requirement for quality products that produce strategic value; establishes stretch goals for self and others; works tenaciously toward achieving desired results.
- Global vision - Thinks globally in terms of commercialization; knows global regulations and protocols; demonstrates cultural sensitivity and works well with people globally; understands what we do as a company even though may not know the details and how they fit in.
- Managing through influence - Motivates and manages the performance of colleagues over whom he/she does not have direct authority; works with and appropriately influences many kinds of team and project members; pushes tasks and decisions down; invites input from others; provides appropriate feedback; steps up to conflicts and handles in an appropriate manner; can find common ground and get cooperation with minimum noise.
- Strong planning and organizational skills - Prioritizes projects and effectively manages resources; effectively coordinates schedules and allocates time to complete work; identifies more critical and less critical activities and tasks and adjusts priorities when appropriate; uses time appropriately to ensure work is completed effectively and efficiently.
- Problem solving - Consistently solves difficult problems with effective solutions; anticipates and identifies core problems, can see underlying or hidden problems and patterns and look beyond the obvious to solve problems effectively; asks good questions and probes for answers; applies insightful analysis; confronts tough or difficult issues.
- Ability to be an effective team leader and/or team member - Comfortable sharing information and working in teams; uses appropriate methods and a flexible style to help build a cohesive team and facilitate the completion of team goals; involves and informs others; models commitment to team expectations and responsibilities; finds ways to help the team accomplish goals.
Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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