Senior Manager, Biostatistics And Programming (Remote)

Stryker is hiring a Senior Manager, Biostatistics and Programming who will support Stryker's Global Trauma & Extremities portfolio. This is a remote position preferably based in the central or eastern time zone.

Who we want

• Accuracy-oriented team leaders. Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts, or reporting.

• Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.

• Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

What you will do

As the Senior Manager, Biostatistics and Programming, you will be responsible for managing the overall operation of Biostatistics and Statistical Programming. You will develop and execute strategies designed to effectively utilize and analyze clinical data sources to generate evidence necessary to support regulatory requirements, commercial, market access, and reimbursement needs according to quality standards, ICH guidelines, and GCP requirements. 

You will work with key stakeholders to develop and deliver biostatistics imperatives, drive innovation, automation and promote transparency within the organization regarding technology, application of systems, and processes.

• Coordinate the development of Biostatistics and Statistical Programming plans. Establish objectives, priorities, time allocations and deadlines for staff.  Execute on plans and provide regular status reports to keep management, and key stakeholders, informed of progress and project issues.

• Leads the Biostatistics and Statistical Programming Team ensuring the continuous improvement and ensure operational compliance.  Ensure planning and co-ordination of project work together with key stakeholders.

• Manage day-to-day Biostatistics and Statistical Programming processes to ensure issues are appropriately evaluated. Review statistical analysis plans and final reports prior to executive approval.

• Establish and maintain strong professional relationships with key external partners (e.g., Academic institutions, ADVAMED, ASA, RSS, etc.) to establish and manage relationships to ensure we keep a pulse check on trends within the wider clinical research industry.

• Provide input and guidance to Clinical Study Teams on biostatistical issues including recommendation of appropriate research design, definition of patient population, measurement of outcome variables, hypothesis development, endpoint specification, study logistics, sample size determination/justification, randomization plans, statistical analysis plans, interim analysis, and stopping rules (if applicable).

• Lead the development, implementation, and maintenance of robust QMS procedures and processes for the area of Biostatistics and Statistical Programming in line with US and International regulations. Participates in internal and external audits as they occur.

• Investigate innovative statistical and Programming practices for possible application.

• Advocate for and participate in cross-functional and cross-divisional work streams to drive best practices and efficiencies across the organization.

• Practice fiscal accountability and stewardship for area of responsibility and follow the wider organization’s resource policies.

• Proactively manage and develop the performance of direct reports through performance management, calibration, talent review and succession planning. Establish development plans and provide training to ensure the capabilities of the team meet both the current and future needs of the business.

• Manage the contracting out of Biostatistics and Statistical Programming project work to CROs or contractors as required ensuring appropriate oversight to the vendor selection process, and SME level review of project work outputs.

What you need

• Bachelor’s Degree required

• Advanced degree (MSc, PhD) in biostatistics, data science, or related field preferred

• Minimum 10 years of experience in a clinical research environment in academia, a contract research organization, and/or the medical device or pharmaceutical industry

• 2-3+ years of line management required

• Knowledge of CDISC models (CDAHS, STDM, ADAM) and experience transforming raw data into those standards. Experience in the FDA e-submission process utilizing such standards is preferred as is SAS certification

• Experience working on projects within the FDA frameworks of 510(k), PMA, NDA, or BLA is desired

• Experience with evidence requirements of EU MDR is essential

• Excellent verbal and written communication skills.

• Exceptional organizational skills, attention to detail, and follow through

• Detailed understanding of the clinical evidence needs in the global regulatory environment for clinical investigation, clinical evaluation, and post-market clinical follow-up of medical devices and technologies.

• Experience working with different statistical modeling and data mining methods utilizing standard statistical software (e.g. R, Python, SQL, SAS, SPSS etc.).

$122,800- $271,400 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

Our benefits:

• 12 paid holidays annually

• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.

• Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits
About Stryker
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.
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