Director Biostatistician R & D Drug Development at Millipore Corporation in BILLERICA, Massachusetts

Job Description:

As Director of Biostatistics, you will play a key role in the success of drug development, as part of a team that encourages career growth and development. As a statistical leader working in a cross-functional team, you will be responsible to develop an appropriate strategy for evidence generation to create value in a drug development program and to support evidence-based decision-making, maximizing probability of success. As Director of Biostatistics, you may independently lead very complex studies or one or more drug projects in study design, data analysis and interpretation of results, authoring regulatory responses and other documents with minimal supervision. Key responsibilities: Provide statistical leadership in the creation of the integrated evidence plan for a drug development program to create value for patients and support marketing authorization and reimbursement. Provide statistical leadership in the development of human research study designs and take accountability for statistical matters, providing matrix leadership of other statisticians.Ensure that statistical analyses are effectively performed and conducted in high quality and in a timely manner and communicated to both technical and non-technical audiences.Ensure the objective interpretation of human research study results to support informed decision-makingRepresent Biostatistics externally, e.g., interaction with Health Authorities, external partnerships, wider statistical community, industry working groups.Provide statistical leadership in the evaluation of in-licensing opportunities, focusing on product value and probability of success.Provide statistical leadership in indication or disease area strategy.Support the development and implementation of departmental standards and process improvements.Contribute to continuous learning and development activities and to the mentoring of junior colleagues.



Who you are:



Minimum RequirementsPh.D. or MS in Statistics, Biostatistics or related discipline Preferred RequirementsAt least 10 years of experience in the Pharmaceutical/Biotechnology industry in clinical developmentExcellent team player (both within the project and within the function), strong communication and influencing skills, fluent in EnglishExperience working in a diverse, global working environment.Comprehensive expertise in drug development, including knowledge of interfaces and interdependencies with other functions.Excellent knowledge of relevant guidance documents (from ICH, FDA, EMA, etc.), using them pro-actively to impact the performance or find alternative solutionsStrong leadership competencies: purposeful, results-driven, innovative, collaborative, future-oriented