Clinical Data & Biometrics Associate Consultant
ZS Associates · Chicago, United States · 26d ago
ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you’ll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS.
Insights & Analytics
ZS's Insights & Analytics group partners with clients to design and deliver solutions to help them tackle a broad range of business challenges. Our teams work on multiple projects simultaneously, leveraging deep domain expertise, advanced data analytics, and problem-solving techniques. Our recommendations and solutions are fit-for-purpose and based on rigorous research and analysis.
What You’ll Do: Decision Analytics Associate Consultant in the Drug Development Practice Area will...
- Lead, or co‑lead workstreams within larger engagements, managing day‑to‑day activities, timelines, and deliverables while ensuring project quality
- Drive clinical data and biometrics transformation initiatives across clinical data management, statistical programming, and biostatistics for pharmaceutical sponsors and CROs
- Work directly with cross-functional teams supporting ongoing and completed Phase I, II, III, and IV clinical trials, contributing to the collection, management, transformation, analysis, and submission of human clinical trial data throughout the study lifecycle
- Analyze current‑state clinical data flows, systems, and standards (e.g., EDC platforms, non‑EDC sources, CDISC SDTM, ADaM) and define future‑state architectures and processes
- Design, specify, or oversee data transformation pipelines that take EDC and non-EDC data from sources systems to submission-ready datasets
- Shape and deliver AI‑focused programs that improve how CDM and SP work is performed (e.g., automation of data review, anomaly detection, edit‑check optimization, programming productivity, documentation generation)
- Partner cross‑functionally with clinical operations, data management, biostatistics, statistical programming, and IT teams, serving as a bridge between technical analytics and business needs
- Collaborate with AI, data science, and technology teams
What You’ll Bring
- Bachelor's or master's degree required in any scientific, analytical, or technical discipline with strong record of academic success
- 3-5 years of relevant post-collegiate experience in clinical data management, statistical programming, biometrics, or related clinical development functions within a pharmaceutical sponsor, biotechnology company, or CRO. Candidates must have direct hands-on experience supporting Phase I, II, III, or IV human clinical trials and working with the systems, processes, and data generated throughout the clinical trial lifecycle. A PhD may substitute in lieu of work experience
- Demonstrated ability to lead workstreams, gather and manage requirements, and collaborate with cross‑functional and client stakeholders in a structured, project-delivery environment
- Ability to act as a client-facing consultant, communicating technical concepts to non-technical audiences and supporting project delivery
- Hands‑on experience with clinical trial datasets, including EDC (e.g., Medidata Rave, Veeva EDC) and non‑EDC sources (e.g., central laboratory data, ECG, ePRO/eCOA, imaging, PK/PD, wearables, real‑world data)
- Demonstrated experience supporting the execution, management, analysis, or submission of data from Phase I–IV human clinical trials. Strong understanding of GCP, clinical trial operations, and regulatory expectations for analysis and submission datasets
- Familiarity with clinical trial data standards (e.g., CDISC, SDTM) and biological/RWE datasets used for reuse in clinical analytics
- Interest in and exposure to AI, automation, or advanced analytics in R&D/CDM/biometrics, and motivation to help clients adopt AI‑enabled ways of working from source to submission
- Fluency in English
- Client-first mentality
- Intense work ethic
- Collaborative spirit and problem-solving approach
Required: Experience directly supporting human clinical trials (Phase I-IV) through clinical data management, statistical programming, biometrics, clinical operations, or related functions. Experience limited to preclinical research, observational studies, real-world evidence, healthcare analytics, or non-interventional data environments will not meet the requirements for this role.
How you’ll grow:
- Cross-functional skills development & custom learning pathways
- Milestone training programs aligned to career progression opportunities
- Internal mobility paths that empower growth via s-curves, individual contribution and role expansions
Perks & Benefits:
At ZS, your growth matters. We offer a comprehensive total rewards package that supports your health and well‑being, financial future, time away, and professional development. With robust skills‑building programs, multiple career progression paths, internal mobility, and a deeply collaborative culture, you’ll have the opportunity to do meaningful work, expand your capabilities, and thrive as part of a global community. For details on total rewards in United States, visit ZS US office locations | Where we work | ZS.
Hybrid working model:
We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections.
Travel:
Travel is a requirement at ZS for client facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures.
Considering applying?
At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems—the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. Learn more about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive.
If you’re eager to grow, contribute, and bring your unique self to our work, we encourage you to apply.
ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.
Work Authorization:
This position is not eligible for visa sponsorship. Candidates must have authorization to work in the United States that does not now or in the future require employer sponsorship.
To complete your application:
An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.
NO AGENCY CALLS, PLEASE.
Find Out More At:
www.zs.com
Insights & Analytics
ZS's Insights & Analytics group partners with clients to design and deliver solutions to help them tackle a broad range of business challenges. Our teams work on multiple projects simultaneously, leveraging deep domain expertise, advanced data analytics, and problem-solving techniques. Our recommendations and solutions are fit-for-purpose and based on rigorous research and analysis.
What You’ll Do: Decision Analytics Associate Consultant in the Drug Development Practice Area will...
- Lead, or co‑lead workstreams within larger engagements, managing day‑to‑day activities, timelines, and deliverables while ensuring project quality
- Drive clinical data and biometrics transformation initiatives across clinical data management, statistical programming, and biostatistics for pharmaceutical sponsors and CROs
- Work directly with cross-functional teams supporting ongoing and completed Phase I, II, III, and IV clinical trials, contributing to the collection, management, transformation, analysis, and submission of human clinical trial data throughout the study lifecycle
- Analyze current‑state clinical data flows, systems, and standards (e.g., EDC platforms, non‑EDC sources, CDISC SDTM, ADaM) and define future‑state architectures and processes
- Design, specify, or oversee data transformation pipelines that take EDC and non-EDC data from sources systems to submission-ready datasets
- Shape and deliver AI‑focused programs that improve how CDM and SP work is performed (e.g., automation of data review, anomaly detection, edit‑check optimization, programming productivity, documentation generation)
- Partner cross‑functionally with clinical operations, data management, biostatistics, statistical programming, and IT teams, serving as a bridge between technical analytics and business needs
- Collaborate with AI, data science, and technology teams
What You’ll Bring
- Bachelor's or master's degree required in any scientific, analytical, or technical discipline with strong record of academic success
- 3-5 years of relevant post-collegiate experience in clinical data management, statistical programming, biometrics, or related clinical development functions within a pharmaceutical sponsor, biotechnology company, or CRO. Candidates must have direct hands-on experience supporting Phase I, II, III, or IV human clinical trials and working with the systems, processes, and data generated throughout the clinical trial lifecycle. A PhD may substitute in lieu of work experience
- Demonstrated ability to lead workstreams, gather and manage requirements, and collaborate with cross‑functional and client stakeholders in a structured, project-delivery environment
- Ability to act as a client-facing consultant, communicating technical concepts to non-technical audiences and supporting project delivery
- Hands‑on experience with clinical trial datasets, including EDC (e.g., Medidata Rave, Veeva EDC) and non‑EDC sources (e.g., central laboratory data, ECG, ePRO/eCOA, imaging, PK/PD, wearables, real‑world data)
- Demonstrated experience supporting the execution, management, analysis, or submission of data from Phase I–IV human clinical trials. Strong understanding of GCP, clinical trial operations, and regulatory expectations for analysis and submission datasets
- Familiarity with clinical trial data standards (e.g., CDISC, SDTM) and biological/RWE datasets used for reuse in clinical analytics
- Interest in and exposure to AI, automation, or advanced analytics in R&D/CDM/biometrics, and motivation to help clients adopt AI‑enabled ways of working from source to submission
- Fluency in English
- Client-first mentality
- Intense work ethic
- Collaborative spirit and problem-solving approach
Required: Experience directly supporting human clinical trials (Phase I-IV) through clinical data management, statistical programming, biometrics, clinical operations, or related functions. Experience limited to preclinical research, observational studies, real-world evidence, healthcare analytics, or non-interventional data environments will not meet the requirements for this role.
How you’ll grow:
- Cross-functional skills development & custom learning pathways
- Milestone training programs aligned to career progression opportunities
- Internal mobility paths that empower growth via s-curves, individual contribution and role expansions
Perks & Benefits:
At ZS, your growth matters. We offer a comprehensive total rewards package that supports your health and well‑being, financial future, time away, and professional development. With robust skills‑building programs, multiple career progression paths, internal mobility, and a deeply collaborative culture, you’ll have the opportunity to do meaningful work, expand your capabilities, and thrive as part of a global community. For details on total rewards in United States, visit ZS US office locations | Where we work | ZS.
Hybrid working model:
We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections.
Travel:
Travel is a requirement at ZS for client facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures.
Considering applying?
At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems—the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. Learn more about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive.
If you’re eager to grow, contribute, and bring your unique self to our work, we encourage you to apply.
ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.
Work Authorization:
This position is not eligible for visa sponsorship. Candidates must have authorization to work in the United States that does not now or in the future require employer sponsorship.
To complete your application:
An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.
NO AGENCY CALLS, PLEASE.
Find Out More At:
www.zs.com