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Clinical Data Systems Specialist
Pierre, SD
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About us Norstella is a premier and critical global life sciences data and AI solutions provider dedicated to improving patient access to life-saving therapies.
Norstella supports pharmaceutical and biotech companies across the full drug development lifecycle — from pipeline to patient.
Our mission is simple:
to help our clients bring therapies to market faster and more efficiently, ultimately impacting patient lives. Norstella unites market-leading brands
Citeline, Evaluate, MMIT, Panalgo, Skipta and The Dedham Group and delivers must-have answers and insights, leveraging AI, for critical strategic, clinical, and commercial decision-making.
We help our clients:
Accelerate the drug development cycle
Assess competition and bring the right drugs to market
Make data driven commercial and financial decisions
Match and recruit patients for clinical trials
Identify and address barriers to therapies Norstella serves most pharmaceutical and biotech companies around the world, along with regulators like the FDA, and payers.
By providing critical proprietary data supporting AI-driven workflows, Norstella helps clients make decisions faster and with greater confidence. Norstella's investments in AI are transforming how data is consumed and decisions are made, disrupting inefficient legacy workflows and helping the industry become more efficient, innovative, and responsive to patient needs. Job description This is a player-manager position within the Content Strategy team in Norstella Content Operations, reporting to the VP, Content Strategy. It combines hands-on strategic ownership with leadership of a small team of technical RWD specialists (two direct reports) who implement the RWD logic and analytical solutions. The role is UK based and remote. The Director sets the direction for RWD/RWE transformational programs and projects that address key business priorities, working in close collaboration with cross-functional business units (Technology, Product, Data Science, Services), and remains directly hands-on in the strategy, evidence logic and specification work that underpins them, focusing on:
Data Optimisation
Drive AI-ready, quality RWE
Data Utilisation
Maximise data utility and unlock opportunities to leverage Norstella RWD data across the business to drive value, including as the foundation for AI solutions and agentic workflows
Thought Partnership
Spearhead data strategy, acting as the SME bridge between client value and Norstella data across both content products and AI-driven solutions
Defensible RWE
own the logic and standards for how real-world evidence is defined, built and defended (cohort definitions, endpoint-based business rules, study design), ensuring outputs are clinically sound, withstand scientific and client scrutiny, and are fit to power both content products and AI solutions and agents
Responsibilities
Serve as an influential RWD/RWE Content SME and thought partner advising senior leadership across Norstella
Set the RWD/RWE strategy
direct how real-world evidence is generated, structured and productised across all therapeutic areas, in service of the broader content strategy
Own cross-functional stakeholder relationships and client engagements across Product, Services, Technology and Data Science, acting as an ambassador for the value of RWE data with internal and external stakeholders and surfacing opportunities for growth and enhancement
Represent RWD as a function across Product, Data Science, Content and Technology
resolving trade offs and providing clear, clinically grounded paths forward
Own the translation of complex, data-driven RWE concepts into business-digestible value and ROI for clients, aligned with enterprise-wide priorities
Ensure clear lines of communication with product and AI teams developing RWE roadmap items
including AI solutions and agents that consume our data
and ensure on-time delivery of data
Report to executive leadership team on progress, risks and implications of strategic initiatives Own the defensible logic and specification of our real-world evidence
Define and govern the standards for cohort definitions, primary and secondary endpoint logic, and real world study design across therapeutic areas (indication-agnostic)
Translate clinical and RWD expertise into precise, buildable specifications and business rules that Data Science and Technology can implement without ambiguity
Provide clear, clinically grounded paths forward when the science, data and product priorities are in tension
acting as the bridge between clinical reality and what gets built and shipped
Ensure the defensibility of RWE outputs is maintained as offerings scale, setting the evidence bar that protects scientific credibility and commercial value
Own the evidence logic, interpretation standards and analytic approach that turn extracted data into actionable insights and strategic recommendations
setting the direction others build to, grounded in prior hands-on data experience rather than routine extraction
Understand the relationship between clinical reality and its imperfect representation in healthcare data
recognising artefacts introduced by coding behaviour, reimbursement processes, site-specific practice and incomplete longitudinal capture, and determining where absence of an event in the data can and cannot reasonably be interpreted as clinical absence
Identify when apparently valid analytical outputs are clinically implausible, and challenge logic that is technically executable but clinically unsound
Apply observational and epidemiological judgement to solution design
critically assessing cohort construction, index dates, follow-up definitions and endpoint selection, and recognising material sources of selection bias, information bias, confounding, censoring, missingness and measurement error
Ensure solutions distinguish appropriately between descriptive observation, association and causal interpretation, and partner with specialist epidemiologists or statisticians where advanced methodological input is required
Establish clinically justified assumptions where RWD is incomplete or ambiguous, identify appropriate proxy measures, and specify edge cases and exception handling required for robust implementation Ownership of end-to-end enhancement of content datasets, leading capability expansion
Spearhead identification of whitespace and structural gaps, and architect feasible, innovative and scalable RWE enhancements to close them
including AI-driven ones
Work with Product and AI teams to scope disease area priorities, definitions and requirements for both content products and AI/agent use cases, thinking strategically and commercially
Ensure content and RWE outputs are AI
and agent-ready
structured, retrievable and semantically consistent so they can be reliably consumed by AI solutions, agentic workflows and downstream products
Define the clinical knowledge, decision logic, constraints and validation requirements for agents interacting with RWD
ensuring AI-enabled outputs distinguish clearly between observed information, calculated outputs, clinical assumptions and inferred conclusions
Develop validation scenarios that test whether agent outputs remain clinically coherent across representative and edge-case patients, identify failure modes where automated interpretation of RWD could mislead, and help establish guardrails so AI increases scale without eroding clinical credibility or transparency
Work with data engineering and technology teams to productionise processes at scale
Assess whether prospective RWD sources can support intended product capabilities and use cases
evaluating longitudinality, completeness, representativeness, granularity, linkage and clinical specificity across EHR, claims, lab, registry and other healthcare datasets
and advise Product teams when data limitations make a proposed capability unreliable or potentially misleading
Establish standards for documenting clinical logic, rationale, assumptions and known limitations, with versioning and governance so reusable logic can evolve as clinical practice, available data and product requirements change
and ensure definitions are not reused outside contexts in which they remain valid. Own and improve the processes and tools used to execute projects effectively Team management
Align with the VP, Content Strategy on team direction and priorities in line with wider Content Strategy priorities
Directly manage and develop a small team of technical RWD specialists (two direct reports) responsible for implementing RWD logic and analytical solutions
providing sufficient clinical context for them to understand the intent behind what they build, reviewing implementation outputs against the approved specification, and remaining close enough to the work to coach and challenge without becoming the primary data extractor or programmer
Direct the team's technical delivery
setting priorities for the ingestion, transformation and standardisation of claims, EHR and registry data into analysis-ready form, and for the data profiling, quality checks and QC review that underpin output reliability
and reviewing that work against the approved clinical specification rather than performing it
Implement performance management structures committed to delivering excellence, ensuring clear development and delivery goals for reports and being accountable for their delivery of those goals
Deliver implementation through the team while personally owning the strategy, evidence logic and specifications they build to
keeping all team members aligned on business priorities and delivering to a regular cadence
Foster leadership development, and mentor and support junior team members
Qualifications
Essential
5+ years' hands-on experience in RWD study design and statistical ownership, working directly with sources such as open/closed claims, lab, EMR/EHR, registries, healthcare coding systems such as ICD 10 and NDC, and drug/medication data. Fluency in US real-world data sources and their respective strengths and limits
Strong clinical expertise is essential
the ability to understand disease and treatment pathways, interpret healthcare data within the context of real clinical practice, identify clinically implausible assumptions or outputs, and reason through ambiguity where clinical reality is only partially represented in the data
together with the demonstrated ability to translate that reasoning into cohort definitions, endpoint-based business rules and precise, buildable specifications
Technical credibility to direct and quality-assure the team's work
hands-on experience with statistical validation techniques, and sufficient fluency in SQL/Python and R and/or SAS to review analytical scripts and outputs, challenge the approach taken and give substantive feedback
Understanding of the evidence needs of biopharma stakeholders across functions such as Clinical Development, Medical Affairs, RWE, HEOR and Market Access, and the ability to translate recurring RWD needs into scalable product capabilities
An MD or equivalent medical qualification is highly desirable. Candidates with other relevant clinical qualifications or backgrounds
Bachelor's or Master's in Life Sciences, Pharmacy, Medical Sciences or equivalent
will be considered where they demonstrate substantial clinical knowledge and the ability to apply clinical reasoning to real-world healthcare data
10+ years' experience preferably in a biopharma intelligence, business research or life sciences consulting domain, including prior direct line management of a small technical or analytical team
Cross-functional influence
experience representing a technical team or function to product, data and commercial stakeholders, driving aligned decisions and building effective working relationships across seniority levels
Experience supporting the development of data, analytics, content or software products in life sciences or healthcare, including building and executing the business case for new capabilities. Strong understanding of the drug development lifecycle, and of how life science data is published, captured and processed to translate real-world events into structured content
Excellent proficiency in Microsoft Office, including SharePoint, Excel and PowerPoint, Monday.com, LucidChart, Jira, Confluence, GitHub
Impeccable or native English verbal and written communication, with previous experience working in global teams Desirable
Knowledge of cloud data warehouses such as Amazon Redshift and Snowflake
Experience integrating RWD/RWE into AI solutions and agentic workflows, or building content to be AI
and agent-ready
Exposure to outcomes research, HEOR, market access or other biopharma evidence-generation use cases, particularly where this has involved the application of real-world data
Our Guiding Principles for success at
Norstella:
01: Bold, Passionate, and Mission-First
02: Integrity, Truth, and Reality
03: Kindness, Empathy, and Grace
04: Resilience, Mettle, and Perseverance
05:
Humility, Gratitude, and Learning Benefits:
US
Medical and Prescription Drug Benefits
Health Savings Accounts (HSA) or Flexible Spending Accounts (FSA)
Dental & Vision Benefits
Basic Life and AD&D Benefits
401k Retirement Plan with Company Match
Company Paid Short & Long-Term Disability
Paid Parental Leave
Paid Time Off & Company Holidays Norstella is an equal opportunity employer.
All job applicants will receive equal treatment regardless of race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, physical or mental disability or handicap, medical condition, sex (including pregnancy and pregnancy-related conditions), marital or domestic partner status, military or veteran status, gender, gender identity or expression, sexual orientation, genetic information, reproductive health decision making, or any other protected characteristic as established by federal, state, or local law. Sometimes the best opportunities are hidden by self-doubt. We disqualify ourselves before we have the opportunity to be considered. Regardless of where you came from, how you identify, or the path that led you here
you are welcome.
If you read this job description and feel passion and excitement, we're just as excited about you. All legitimate roles with Norstella will be posted on Norstella's job board which is located at norstella.com/careers. If a role is not posted on this job board, a candidate should assume the role is not a legitimate role with Norstella. Norstella is not responsible for an application that may be submitted by or through a third-party and candidates should proceed with extreme caution if a third-party approaches them about an open role with Norstella. Norstella will never ask for anything of value or any type of payment during or as part of any recruitment, interview, or pre-hire onboarding process. If you are aware of or have reason to believe a job posting purportedly for a role with Norstella is fraudulent or otherwise not authorized by Norstella, please contact the Company using the following email address: [email protected] .Norstella is an equal opportunity employer. All job applicants will receive equal treatment regardless of race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, physical or mental disability or handicap, medical condition, sex (including pregnancy and pregnancy-related conditions), marital or domestic partner status, military or veteran status, gender, gender identity or expression, sexual orientation, genetic information, reproductive health decision making, or any other protected characteristic as established by federal, state, or local law.