Sr Statistician

Job Summary:

• In this exciting role as a Senior Statistician, you will have primary focus responsibility to support innovative cardiovascular device clinical trials and contribute to efforts in the field of advanced analytics and data solutions.
• The Senior Statistician will support Cardiac Rhythm Management (CRM), Cardiac Ablation Solutions (CAS), Cardiovascular Diagnostics & Services (CDS) and Mechanical Circulatory Support (MCS).
• Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure.
• It is comprised of four key businesses: Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure.

Responsibilities:

• Validates statistical analyses performed by other team statisticians (using R or SAS programming languages).
• Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products.
• Uses sound statistical methodology to conduct studies relating to the life cycle of the product.
• In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
• Develops and/or applies statistical theories, methods, and software.
• Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used.
• Provides specifications and directions to the clinicians/statistical programmers.
• Supports the regulatory review and approval of the experimental therapies.
• May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.

Education, Experience and Skills:

• Bachelor’s degree with a minimum of 4 years of statistical experience (e.g., statistical modeling, biostatistics)
• Advanced degree with a minimum of 2 years of statistical experience (e.g., statistical modeling, biostatistics)
• Master’s degree (or above) in statistics/biostatistics or relevant fields.
• 2+ years post graduate experience in medical research.
• Understanding of statistics and machine learning methods, ability to continue self-learning of technical and non-technical skills.
• Demonstrated proficiency in SAS, R or Python and experience with low level languages, including C/C++.
• Prior experience in FDA and/or global regulatory submissions.
• Experience with adaptive designs, Bayesian modeling, sequential data, computational statistics.
• Experience in processing large data from various data sources.
• Experience in handling of protected patient health information.
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g. ISO, MDD/MDR, CFR).
• Insatiable desire to learn, to innovate, and to challenge themselves for the benefit of patients.

Differentiating Factors:

Autonomy:

• Seasoned individual contributor.
• Works independently under limited supervision to determine and develop approach to solutions.
• Coaches and reviews the work of lower-level specialists; may manage projects / processes.

Organizational Impact:

• May be responsible for entire projects or processes within job area.
• ​​​​​​​Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity:

• Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
• ​​​​​​​Makes improvements of processes, systems or products to enhance performance of the job area.
• Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence:

• Communicates with senior internal and external customers and vendors.
• ​​​​​​​Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.

Leadership and Talent Management:

• May provide guidance, coaching and training to other employees within job area.
• ​​​​​​​May manage projects, requiring delegation of work and review of others’ work product.

Interview: 

• MS teams Virtual Interview No Coding assessment test.