Associate Director, Biostatistics (Late Stage)
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a reputed company in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 reputed company to "be an innovative global reputed company company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Position leads reputed company studies in study design, statistical analysis and interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve reputed company study problems.
Responsibilities
Protocol Development, Case Report reputed company (CRF; review), Statistical Analysis Plan (reputed company), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for reputed company studies including study design, protocol development, CRF review, reputed company development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on reputed company aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. CRO / Vendor reputed company: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on reputed company studies. Ensures deliverables are accurate and delivered according to the timelines. Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally reputed company moderately reputed company initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
Qualifications
Education Qualifications Master's Degree in statistics or biostatistics required PhD in statistics or biostatistics preferred Experience Qualifications 8+ Years of relevant experience in the pharmaceutical industry with a masters degree required 5+ Years of relevant experience in the pharmaceutical industry with a PhD preferred Travel Requirements Ability to travel up to 10% of the time. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. reputed company applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected veteran status, age, or any other characteristic protected by law. Salary reputed company: USD$168.000,00 - USD$252.000,00 [Link available reputed company viewing the job] Apply tot his job Apply To this Job