International Business Machines Corp. (IBM Corporation)
Preferred location Cambridge, MA or Armonk, NY.
The newly formed IBM Watson Health business unit is looking for talented individuals destined to usher in the next era of healthcare. We live in a moment of remarkable change and opportunity for the use of Cognitive Insights in Healthcare Delivery, treatment and population management. The convergence of data and technology is transforming healthcare and life sciences organizations in every way. New roles are being created that never existed before to meet the demands of this transformation.
We have an exciting opportunity for a Biostatistician with demonstrated expertise in clinical study design and analysis, who specializes in statistical methodologies used to support analytical and clinical validation of medical technology slated for global regulatory submissions, as well as products in post-market settings. Working both independently and in collaboration with scientists, engineers and other statisticians, you will provide advanced statistical and analytical expertise in both regulated and non-regulated settings, to support Watson Health solution teams with product development and manufacturing release delivery of compliant platforms and solutions to customers. You will use your knowledge of clinical study design and biostatistics to provides technical leadership, knowledge, experience and expertise by planning, conducting and supervising clinical development and evidence management projects. You will contribute to the clinical development strategy and ensure statistical integrity, optimal study designs and data and evidence needs are reflected and fulfilled within that strategy. To achieve Watson Health objectives, you provide out-of-the-box thinking to develop innovative clinical study designs, quantitative decision making and the incorporation of evidence from disparate sources of big data (for example, digital technology, real world evidence and other datasets compiled from pre and post-market data collection initiatives). Critical deliverables include the design and formulation of statistical methodologies and input that ensure quality and consistency of key data deliverables across studies. You will analyze data and prepare and review study protocols, statistical analysis plans, interim study reports, manuscripts, abstracts and other technical documents and procedures pertaining to statistical methods.
As a Watson Health Biostatistician you will:
Be an integral member of product development team responsible for supporting claims development, and data management in clinical studies.
Possess data management expertise and advanced knowledge in biostatistical concepts and practical application of such concepts to the assessment of medical device technology.
Serve as a subject matter expert in biostatistics, epidemiology, data mining, data analytics, and data management.
Provide study design and biostatistical guidance to Offering Management, Marketing and Development teams.
Provide functional excellence in the areas of statistics, data analysis and data processing for the department.
Apply extensive fundamental and specialized knowledge to the development of clinical protocols for device validation, respond to FDA questions, implementing new approaches to automated data processing for clinical trials.
Propose new ideas and recommend implementation plans leading to enhanced efficiencies and faster review and analysis of data.
Provide statistical input and advice to clinical teams for the design of studies and sample size/power estimations, including the design, writing and review of study protocols, development of statistical analysis plans and development of analyses requiring advanced statistical methodologies.
Design and lead the preparation of statistical components of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
Lead the analysis, evaluation and planning for methods of approach, and organizes means to achieve the solution to highly complex problems.
Interpret and evaluate statistical data and results of the most complex investigations and develop appropriate recommendations.
Lead the development of reports, charts, graphs, and other documents which support claims recommendations.
Lead building the data and evidence compendium for Watson Health offerings.
Review and approve related inputs such as statistical analysis and specifications prepared by technical support personnel.
Lead the delivery of specifications and directions to clinical programmers.
Support develop the standards for clinical conduct, data collection, management and/or reporting.
Provide clear and regular technical and administrative input to professional, technical and administrative personnel assigned to a project.
Recognize and address issues which may impact the statistical integrity of the evidence development program or recognition of datasets for which different statistical tools may add value.
Successful candidates will possess the following key attributes:
PhD or MS degree with a minimum of 5 years of experience. Experience with clinical decision support systems and/or software as a medical device is critical.
Demonstrated experience of applying statistical methods in biomedical research, pharmaceutical, medical device or CRO experience is required.
Good knowledge of ICH GCP guidelines, FDA regulations and demonstrated experience with pharma and/or medical device clinical trials and FDA/NDA submissions is required.
Experience with study design methodology such as adaptive design or pragmatic clinical trials, state-of-the-art modeling approaches, incorporation of real word evidence or experience analyzing big data.
Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solutions to novel problems.
Sound knowledge of statistical methodologies such as analysis of variance, regression, experimental designs, contingency tables.
Expertise with SAS and R.
Ability to work independently and in project teams.
Excellent communication skills (written and spoken).
Required Technical and Professional Expertise
At least 5 years of work experience in a Healthcare medical device or Life sciences pharmaceutical regulated process mature environment
Preferred Tech and Prof Experience
At least 7 years of work experience in a Healthcare medical device or Life sciences pharmaceutical regulated process mature environment
IBM is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
International Business Machines Corp. (IBM Corporation)
Website : http://www.ibm.com/
International Business Machines Corporation provides information technology (IT) products and services worldwide. The companys Global Technology Services segment provides IT infrastructure and business process services, including outsourcing, process, integrated technology, cloud, and technology support. Its Global Business Services segment offers consulting solutions for strategy and transformation, application innovation, enterprise applications, and smarter analytics; and application management, maintenance, and support services. International Business Machines Corporations Software segment offers middleware and operating systems software, such as WebSphere software to integrate and manage business processes; and information management software for database and enterprise content management, information integration, data governance, data warehousing and analytics, business analytics and intelligence, and predictive analytics. This segment also provides Tivoli software for cloud and datacenter management, enterprise endpoint and mobile device management, asset and facilities management, storage management, and security systems; Rational software that supports software development; and Mobile Software for platform and application development, mobile security, and mobile device management. The companys Systems and Technology segment provides computing power and storage solutions; and semiconductor technology, products, and packaging solutions. Its Global Financing segment provides lease and loan financing to end users; commercial financing to dealers and remarketers of IT products; and remanufacturing and remarketing services for equipment. The company was formerly known as Computing-Tabulating-Recording Co. and changed its name to International Business Machines Corporation in 1924. International Business Machines Corporation was founded in 1910 and is headquartered in Armonk, New York.