Manager Biostatistics
vor 3 Wochen
Passion for Innovation. Compassion for Patients.
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
For our European Headquarter in Munich we are seeking qualified candidates to fill the position:
Manager Biostatistics (m/f/x)
The Position:
Position leads statistical support for medium complexity studies including contributing to development of optimal study design, independently develop and execute statistical analysis plan and helps in 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 works on statistical methodology and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal programmers 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 complex study problems.
Roles and responsibilities:
Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity studies including study design, protocol development, CRF review, SAP 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 all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer. 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 Oversight: 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 complex 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 strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex biostatistical 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.
Personal skills and professional experience:
PhD in statistics or biostatistics Master's Degreein Statistics/Biostatistics 4 or More Years relevant experience in the pharmaceutical industry with Ph.D 4 or More Years with Masters. Strong knowledge of statistical methodologies. Good understanding of current drug development trends and regulatory environments. Excellent programming skills in SAS and/or R and working knowledge of software such as nQuery, East, etc. Strong analytical and problem solving skills and able to provide guidance to lower level biostatisticians in solving problems. Working knowledge of pharmacology, clinical research, and medical terminology and use it for study design and results interpretation. Excellent oral and written communication skills. Ability to identify and investigate issues and causes and formulate potential solutions with some supervision Ability to prioritize multiple tasks, develop instructions and manage vendors and collaborate with internal programming colleagues in completing the deliverables with high quality according to timelines, and provide recommendations to improve process Compliant with internal and external compliance practice to ensure integrity of work and suggest innovative approaches to improve compliances and processes Working knowledge of clinical trial methodologies.
Why work with us?
Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
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