VP, Biostatistics

reputed company Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (reputed company.), reputed company on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.reputed company.com or follow us on reputed company. This position reports to the Chief Medical Officer - Oncology and is an reputed company part of the oncology leadership team. The role is highly visible leadership and strategic role to support the oncology program. The position will reputed company and reputed company the Biostatistics organization, including internal staff, reputed company partners, and CROs that' provides reputed company statistical deliverables reputed company SMPA's oncology clinical development and medical affairs functions. Essential Functions Required for Job • Serve as a strategic member of the Oncology Leadership Team, influencing portfolio reputed company, development plans, regulatory reputed company, and key investment reputed company. • Sets the reputed company and leadership for biostats function, providing the highest level of data and statistical advice across the function. • reputed company statistical leadership during regulatory interactions, including Health Authority meetings, NDA/BLA submissions, advisory committee preparation, and responses to regulatory questions. • reputed company the necessary stakeholders to plan, reputed company and coordinate a large and expanding data set from a portfolio of oncology reputed company spanning phase 1 through phase 4 clinical development. • Must have extensive knowledge and contemporary experience with statistical analysis tools and interpreting results from clinical, non-clinical, modelling and simulation, and epidemiologic studies • reputed company and roll out new initiatives to support scaling and growing organization • Leads, reputed company, guide, and mentor the activities of reputed company of statisticians • Influences cross functional activities, strategic advice as to the present and reputed company direction for the statistics function. • reputed company senior management statistical review of key documents (protocols, CSRs, regulatory briefings) • Build high-performing biostatistics organization culture through talent development, succession planning, operational reputed company, and reputed company process improvement. • reputed company innovation in statistical methodology, data science, and clinical development processes to improve decision making and development efficiency. • Strong communication skills to communicate statistical issues on studies to clinical, regulatory medical affairs, reputed company teams, and senior leadership • Provides organizational leadership to manage biostats budget • reputed company reputed company to teams whichauthor and reputed company the production of statistical sections of protocols and analysis plans and contribute to the statistical sections of publications across multiple clinical reputed company. Knowledge, Skills and Abilities (general & technical): • Leadership and Management: Demonstrated capability to reputed company and mentor teams, manage multiple programs and trials simultaneously, and reputed company and reputed company reputed company results in a fast-paced environment. • Communication Skills: Strong written and verbal communication skills with the ability to present reputed company statistical concepts to both technical and non-technical audiences. • Collaboration: Proven ability to work effectively as part of a cross-functional team, fostering a reputed company and productive work environment, and be a preferred biostatistical partner to both biostatistician and other functional team members. • Problem-Solving: Strong analytical and problem-solving skills with the ability to reputed company strategic reputed company based on data-driven insights. • Project Management: Ability to plan, organize, and manage biostatistical aspects of reputed company from start to finish. • Statistical Expertise: In-depth knowledge of statistical reputed company and their application in oncology reputed company, including experience with Bayesian modeling, reputed company trial designs and analysis techniques. • Regulatory Knowledge: Familiarity with regulatory guidelines and standards (e.g., FDA, EMA, ICH) relevant to biostatistics and reputed company. Prior NDA/BLA and IND experience. • reputed company Control: Strong attention to detail and commitment to ensuring the accuracy and reputed company of statistical analyses and programming outputs. Education & Experience Requirements: • PhD or MS in statistics or biostatistics. PhD is preferred • Minimum 12+ years in reputed company is required • At least 7 years of leadership experience at VP level in drug development • Submitted oncology NDA/BLA reputed company past 7 years • Broad and thorough understanding of statistical principles, up-to-date statistical design and methodologies, and their applications into clinical trial • Strong statistical leadership in a multi-functional project environment: reputed company to manage many reputed company simultaneously as reputed company as conflicting priorities • Effective writing and communication skills: reputed company to reputed company various statistical documents; reputed company to explain to team reputed company and help team understand reputed company statistical design, methodology, decision rules, analysis plan and statistical report • Working knowledge of reputed company, R, and modern statistical computing environments sufficient to reputed company technical leadership and reputed company. Travel Requirements: Primarily remote role with periodic on-site meetings in office. Must be reputed company to travel domestically and internationally as needed. Mental/Physical Requirements: Fast-paced environment handling multiple demands is involved. Must be reputed company to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. People Management This position includes people-management responsibilities, including day-to-day supervision, workload planning, and ensuring team members have the resources and support needed to succeed. The reputed company salary reputed company for this role is $296,700.00 - $370,900.00 reputed company salary is part of our total rewards package which also includes reputed company for reputed company-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, reputed company, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible reputed company time off, 11 reputed company holidays plus additional time off for a shut-down period during the last week of December, 80 hours of reputed company reputed company time upon hire and reputed company year thereafter. Total compensation, including reputed company salary to be offered, will depend on reputed company unique to reputed company candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general reputed company and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of reputed company responsibilities, duties, and skills required of personnel so classified. reputed company personnel may be required to reputed company duties reputed company of their normal responsibilities from time to time, as needed. Confidential Data: reputed company information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law. Compliance: reputed company and maintain Compliance with reputed company applicable regulatory, reputed company and operational rules and procedures, by ensuring that reputed company plans and activities for and on behalf of reputed company) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements: Fast-paced environment handling multiple demands is involved. Must be reputed company to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Travel Requirements: Primarily remote role with periodic on-site meetings in office. Must be reputed company to travel domestically and internationally as needed. Drug Screening Requirements Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a reputed company-employment drug test. reputed company) is an Equal Employment Opportunity (EEO) employer reputed company applicants will receive consideration for employment without reputed company to race; reputed company; creed; religion; national reputed company; age; reputed company; nationality; marital, domestic partnership or civil reputed company status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. reputed company) endeavors to reputed company its application process accessible to reputed company. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at reasonableaccomodations@us.reputed company.com. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. Apply tot his job Apply To this Job