Statistics and Programming Lead (Remote),

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Your role at Baxter

This is where your expertise helps people

This position is responsible for providing strategic and tactical direction for statistical activities at the project and organizational levels. Ensures that proper statistical and pharmacokinetic analyses and interpretation are followed. Manages a team of statisticians and Programmers.

What You'll Be Doing

Directly (or indirectly via their staff) provide scientific and statistical / programming leadership for clinical trials including recommendation of appropriate research, sample size, appropriate statistical methodology, definition of patient and analyses populations, measurement of outcome variables, and hypothesis development.Author and/or provide input on statistical sections of clinical study documents including protocols, electronic case report forms, randomization plans, data transfer specifications, statistical analysis plans, tables, listings, and figures (TLF) shells, SDTM/ADaM specifications, clinical study reports, and other relevant documents.Lead the development and approval of global Statistics / Programming strategies in collaboration with colleagues.Represent Statistics function when interacting with global regulatory authorities, which may include contributing to regulatory submission preparation, responses to questions, and preparation for advisory panelsManage Contract Research Organization (CRO) statistics activities, as needed.Manage data release and review meetings for clinical projects; present final analysis results to key stakeholders; review and participate in finalizing and obtaining approval of final manuscript(s) or final reports for projects.Ensure organization continues to monitor and apply any changing methodologies or regulationsProvide direct management of the Statistical / Programming resources across Clinical and Nonclinical; train and mentor staff on applicable technical approaches in delivering outcomes

What You'll Bring

Strong leadership and communication skills (i.e., Collaboration & Teamwork, Scientific Concepts & Research Design, Biostatistics & Programming, Decision Making & Risk Management, Vendor / Supplier Management, and Product Life-Cycle Development Process)Working knowledge and proficiency in SAS, Statistical tools, EDC, CDISC standards, industry standards, data structures / formats, and other applicable areas within statistics and programming.Experience or willingness to learn and further the organizations expertise in innovative and applicable statistical methodologies (i.e., Adaptive Design, Bayesian, and others)Ability to work within a matrix organization, lead through others while leveraging technical and leadership experience to influence decisions related to the function’s responsibilities.Ability to manage multiple priorities while maintaining performance (i.e., functional team, individually, and organizational initiatives)Good organizational skills (i.e., demand/capacity, functional strategies, objectives, priorities, financials, etc.) and written/verbal communication.Knowledge of the drug discovery and development process, clinical trial methodology, worldwide regulatory requirements and the medical device business.Experience managing statistics / programming team and leveraging third party services to augment capacity needs within the function preferred.

Education And/or Experience

Masters/PhD in Statistics

Minimum of 5+ years recent related clinical experience

Experience with different clinical phases

Management Experience Preferred

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $128,000 to $176,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonus. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law

EEO is the law - Poster Supplement

Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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