About the Opportunity

Our commercial team is growing and looking for a Clinical Account Manager based in Nashville/Raleigh
to help support our growth. You will play a critical role in supporting Cleerly’s growth and
success of current clients/partners by making sure they understand our product offerings and
helping patients get Cleerly scans. Reporting to the Regional Director of Sales, this role will be
working with clinical partners to find expansion opportunities as well as to provide ongoing
clinical education to grow existing Cleerly accounts.

You will be responsible for identifying growth opportunities, maintaining relationships with
existing high-value partners, and representing Cleerly as a leader in the industry to positively
impact the lives of millions. The ideal candidate is highly motivated, has a clinical background, is
client focused, result-oriented, and mission-driven. You will work with clinics to ensure that they
are extremely successful with Cleerly’s cardiovascular diagnostic technology by proactively
supporting, educating, and providing high customer satisfaction. This is a customer- facing role
with a primary focus on spending time with customers including Cardiologists. This is a
field-based role, but you must be based in or near Nashville/Raleigh, as it will be a key market in
your assigned territory. 

Responsibilities

• Manage and maintain relationships with clinical partners to make sure they understand
  Cleerly and how Cleerly helps Providers in their treatment decisions for patients.

• Account development - Experience building and supporting strong clinical programs is
  preferred.

• Clinical / technical proficiency - Quick learner able to grasp new clinical/technical
  information and then disseminate to customers.

• Develop relationships with key account stakeholders, to include admin, admin support,
  key cardiologists, key referring physician practices, and key strategic personnel to drive
  awareness of Cleerly’s offerings and promote adoption.

• Customer-focused mentality.

• Drive new product and technology introductions for existing customers.

• Develop a qualified lead funnel within the existing base. Regular activities consist of
  formal presentations, peer-to-peer education, new physician training, and driving
  physician education.

• Use Salesforce.com to manage administrative tasks.

• Travel to various provider sites within a territory 50-80% of the time including the following states: NC, TN

Requirements

• Degree from accredited college/university.
• 5+ years of related sales or clinical experience (PA, NP, DNP or RN).
• Prior experience in medical device, cardiology pharmaceuticals, cardiology
  radio-pharmaceuticals, hospital, or medical software is highly desired.
• Highly coachable with the ability to learn and communicate complex programs and value
  propositions.
• Strong interpersonal and relationship-building skills, polished communications, the ability
  to manage multiple customer and internal company interactions.
• Effective project management skills while embracing change and driving solutions in
  otherwise chaotic environments.
• Exceptional written and verbal communication skills.
• A hard-worker, self-motivator with can-do approach and bias for action.
• Highly responsive with the ability to interpret appropriate next step actions.
• Ability to collaborate cross-functionally with both internal and external stakeholders
  across a vast geographic region.
• Experience with introducing new cardiovascular technologies into hospitals is highly
  desired.
• Ability to accurately assess and understand different stakeholders needs/wants. Process
  cross functional agendas and adjust strategy to achieve desired outcomes.
• Grit, high integrity, values-based work ethic.

The base salary range for this role is aligned to market benchmarks and determined by experience, skills, and internal equity.

This role is eligible for annual On Target Commission, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $130,000 - $140,000
• Commission: $90,000
• TTC: $220,000 - $230,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

Cleerly is seeking a Senior Client Success Manager to own and manage client relationships within a defined territory. This role will serve as the day-to-day liaison for healthcare clients—ensuring successful onboarding, driving adoption, addressing concerns, and promoting long-term satisfaction and expansion.

The ideal candidate will have experience in healthcare or health tech, demonstrate strong communication and relationship-building skills, and bring a data-driven mindset to proactively manage client health and success.

About the Team

The Client Success role is pivotal in ensuring strong, long-lasting relationships with our clients. This position is responsible for managing day-to-day communication, acting as the main liaison between the client and our internal teams. By owning the client relationship, the Client Success Managers ensure that all client needs, concerns, and goals are addressed in a timely and effective manner. They represent the client's voice internally, advocating for their interests and ensuring alignment with our company’s objectives.

This role reports directly to the VP of Client Success and works daily with Implementation, Sales, and Product amongst other teams. 

Responsibilities

Client Ownership & Relationship Management

• Serve as the primary point of contact for clients within the assigned territory
• Build strong, trusting relationships with clinical and administrative leaders at hospitals, imaging centers, and cardiology practices
• Conduct regular business reviews, utilization assessments, and check-ins to ensure client satisfaction and retention
• Meet key performance indicators (KPIs) for the Client Success team, including Net Promoter Score (NPS), client retention (volume, logo), and referenceability. Use data-driven insights to continuously improve client success initiatives and enhance client satisfaction

Onboarding & Adoption

• Partner with Client Services and Implementation teams to ensure seamless onboarding and launch of Cleerly solutions
• Drive initial and ongoing adoption through best practices, education, and alignment with client goals
  
  

Client Health Monitoring

• Track key client metrics (utilization, turnaround times, NPS, etc.) and proactively identify and resolve risks to success
• Leverage internal data to provide strategic insights to clients and recommend workflow enhancements

Retention & Growth

• Collaborate with Sales and Partnerships to identify opportunities for renewals, upsells, and expansion
• Champion the voice of the customer internally, contributing feedback to product and service teams

Cross-Functional Collaboration

• Act as the bridge between clients and internal teams (Sales, Product, Clinical, Marketing) to ensure alignment and excellence in service
• Support pilots and product rollouts specific to your territory’s client base
  
  

Requirements

• Bachelor’s degree; background in healthcare, life sciences, or business is preferred
• 7 + years of experience in client success, account management—preferably in a healthcare or SaaS environment
• Experience working directly with health systems, cardiology groups, or outpatient imaging centers is highly desirable. 
• Startup (Series A-C) experience preferred, not required.
• Exceptional communication, interpersonal, and problem-solving skills
• Self-starter with strong organizational skills and the ability to manage multiple accounts with minimal supervision
• Familiarity with CRM platforms (Salesforce preferred) and data dashboards (e.g., Tableau or Looker)
• Willingness to travel within the territory (up to 40%)
• Spanish speaking is a plus but not required

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $135,000-145,000
• TTC: $155,250-166,750

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

Brief team/department description:

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. This person will play a critical role by determining that clinical strategies meet Health Authority regulatory requirements for investigational and approved marketing applications, as well as providing clinical strategic support for due diligence activities.  The Regulatory Affairs Director- Clinical Strategy will report to the Senior Director, Head of Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Franchise Managers, Clinical Development, Medical Affairs, and Product Development.

 Principle Responsibilities:

• Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements
• Provide critical evaluation and review of clinical documents to support successful execution of regulatory objectives; proactively identify potential risks and develop implement mitigation strategies
• Interact with and support the Azurity Clinical Development and Medial Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input
• Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy
• Demonstrate knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics
• Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings
• Mentor, develop and act as a trusted advisor to coach members of the regulatory team regarding clinical strategy and writing; this position may or may not have direct reports

CORE Responsibilities

• Authoring, preparation and/or review of relevant clinical sections of regulatory applications such as INDs, NDAs, BLAs, including ISS and ISE, initial pediatric study plans, waivers, clinical and non-clinical sections
• Assessment of regulatory and critical clinical approval factors including but not limited to PK, PREA and other post-marketing safety studies
• Evaluation and determination of regulatory pathways within relevant therapeutic areas to provide insight into potential development opportunities to support and build the Azurity R&D pipeline
• Evaluation and analysis of available literature for the development of bridging strategies required to support 505(b)2)NDA submissions
• Authoring, preparation and/or review of sections of various FDA communications including, but not limited to Information Requests, Priority Review and Orphan Drug Designation requests
• Preparation and/or review of Agency meeting documents including meeting requests and briefing documents; lead FDA meetings/interactions regarding regulatory clinical discussions
• Authoring, preparation and/or review of clinical and nonclinical sections of drug product labeling
• Represent Regulatory Affairs at cross-functional team interactions to provide clinical strategic input
• Provide strategic clinical regulatory support for due diligence projects across various therapeutic areas and dosage strengths

Qualifications and Education Requirements

• 10+ years of pharmaceutical industry experience within Regulatory Affairs, strong scientific and regulatory background
• Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs
• Experience leading teams, coaching, and fostering a culture of efficiency and teamwork
• Ability to adapt to rapidly changing environments and circumstances, requiring a sense of urgency while ensuring that all cGMP and regulatory requirements are met
• Strong communication skills (written and verbal) demonstrated ability to express complex information clearly and concisely
• Bachelor’s degree in a scientific discipline or other closely related discipline is required; advanced degree preferred (MS, PharmD, PhD)

#LI-Hybrid

If you are looking to be a part of a dynamic, global, fast-growing organization, have a positive attitude, willing to develop yourself, and are energized by being a part of improving the health of others, we are the perfect match for you. By joining us as the Global Head of Regulatory Affairs your position will be broad, communication between departments will be fast and effective and you will have significant responsibility and autonomy for your work and contributions.

As the Global Head of Regulatory Affairs working on the Global Regulatory Affairs team you will be empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and multiple projects.

Principle Responsibilities:

• Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan. Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of all regulatory projects. Ensures compliance for global regulatory requirements.
• Is a leader, contributing to cross-functional initiatives and influencing as applicable and demonstrating leadership behaviors.
• Directs and oversees multiple projects (inclusive of highly complex ones), generally has global/regional oversight for assigned products, this includes oversight to ensure regulatory compliance (e.g. on registration database) by staff and / or vendor.
• Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility. Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications.
• Provides leadership and development for direct reports, including those that serve as regional regulatory leads responsible for the design and execution of regional regulatory strategies.
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
• Accountable for all global submissions and approvals of project(s) and/or oversees direct reports responsible.
• Oversees all submissions.
• Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of RA team, as necessary.
• Accountable for working with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided in compliance with local regulations. And to maintain compliance for products.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

Qualifications and Education Requirements:

• MD, PhD or PharmD in a scientific discipline preferred along with 15+ years of experience in Regulatory Affairs
• Proven success in regulatory submissions.
• FDA, EU, Canada, ROW, and post-marketing experience is a plus with sound knowledge of such principles as GxP's, FDA, and EU guidelines.
• Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
• Experience with investigational drugs, including late stage development, and marketed products
• CRO management experience preferred.
• Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable
• Must be a strong leader that creates a vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
• Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Strategic thinker, planner, and implementer with excellent organizational skills.
• Excellent oral and written communication skills and knows how to present data/issues both to a technical and non-technical audience with the ability to write and edit regulatory documents.
• Able to plan and execute regulatory projects, and proven record of delivering results within business-defined timeframes.
• Proven ability to work on complex problems where analysis of the situation or data requires an evaluation of intangible variables.
• Demonstrates potential for a high level of collaboration with others and within global teams.
• Independent thought, negotiation skills, integrity, and adaptability.
• Ability to work on own and in virtual setting.
• MS Office skills with excellent use of excel, PowerPoint and MS Project required.
• Recent experience with a smaller entrepreneurial environment is a definite asset.
• Fluent in English (written and oral).

#LI-Hybrid

If you are looking to be a part of a dynamic, global, fast-growing organization, have a positive attitude, willing to develop yourself, and are energized by being a part of improving the health of others, we are the perfect match for you. By joining us as the Global Head of Regulatory Affairs your position will be broad, communication between departments will be fast and effective and you will have significant responsibility and autonomy for your work and contributions.

As the Global Head of Regulatory Affairs working on the Global Regulatory Affairs team you will be empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and multiple projects.

Principle Responsibilities:

• Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan. Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of all regulatory projects. Ensures compliance for global regulatory requirements.
• Is a leader, contributing to cross-functional initiatives and influencing as applicable and demonstrating leadership behaviors.
• Directs and oversees multiple projects (inclusive of highly complex ones), generally has global/regional oversight for assigned products, this includes oversight to ensure regulatory compliance (e.g. on registration database) by staff and / or vendor.
• Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility. Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications.
• Provides leadership and development for direct reports, including those that serve as regional regulatory leads responsible for the design and execution of regional regulatory strategies.
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
• Accountable for all global submissions and approvals of project(s) and/or oversees direct reports responsible.
• Oversees all submissions.
• Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of RA team, as necessary.
• Accountable for working with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided in compliance with local regulations. And to maintain compliance for products.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

Qualifications and Education Requirements:

• MD, PhD or PharmD in a scientific discipline preferred along with 15+ years of experience in Regulatory Affairs
• Proven success in regulatory submissions.
• FDA, EU, Canada, ROW, and post-marketing experience is a plus with sound knowledge of such principles as GxP's, FDA, and EU guidelines.
• Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
• Experience with investigational drugs, including late stage development, and marketed products
• CRO management experience preferred.
• Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable
• Must be a strong leader that creates a vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
• Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Strategic thinker, planner, and implementer with excellent organizational skills.
• Excellent oral and written communication skills and knows how to present data/issues both to a technical and non-technical audience with the ability to write and edit regulatory documents.
• Able to plan and execute regulatory projects, and proven record of delivering results within business-defined timeframes.
• Proven ability to work on complex problems where analysis of the situation or data requires an evaluation of intangible variables.
• Demonstrates potential for a high level of collaboration with others and within global teams.
• Independent thought, negotiation skills, integrity, and adaptability.
• Ability to work on own and in virtual setting.
• MS Office skills with excellent use of excel, PowerPoint and MS Project required.
• Recent experience with a smaller entrepreneurial environment is a definite asset.
• Fluent in English (written and oral).

#LI-Hybrid

Brief team/department description:

As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior Associate will assist in preparing, review and submission regulatory filings to the FDA and other global health agencies.  The person will play crucial role in managing lifecycle of IND, NDA, ANDA, etc. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.

Principle Responsibilities:

• Provide regulatory assistance with due diligence requests to support new business development activities.
• Support interaction with FDA and other regulatory agencies for assigned commercial products.
• Assist in compiling and authoring regulatory filings (IND, NDA, ANDA, etc.) and post marketing supplements for assigned products.
• Manage the timelines associated with regulatory submissions such as post-marketing periodic reports.
• Manage archival of regulatory submissions, regulatory correspondence and associated logs and tracking mechanisms.
• Provide regulatory guidance on requirements for post-approval changes, as required, for assigned products.
• Review and provide regulatory assessments for change control documentation.
• Provide regulatory support to regulatory leadership meetings and presentations.
• Keep abreast of current regulations and regulatory guidance, assessing impact to assigned products and internal processes.
• Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department.
• Other duties as assigned.

Qualifications and Education Requirements

• Minimum of Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.
• Minimum of 3 years in the pharmaceutical industry with at least 1 of those years in regulatory affairs.
• Combination of education and applicable job experience may be considered.
• Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.​
• Ability to work independently with minimal supervision in a fast-paced deadline driven environment​.
• Keen attention to detail.
• Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and regulatory requirements are met​.
• Ability to successfully communicate, negotiate and influence regulatory strategy to key stakeholders.

#LI-Hybrid
#LI-Full-time

Brief team/department description:

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. This person will play a critical role by determining that clinical strategies meet Health Authority regulatory requirements for investigational and approved marketing applications, as well as providing clinical strategic support for due diligence activities.  The Regulatory Affairs Director- Clinical Strategy will report to the Senior Director, Head of Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Franchise Managers, Clinical Development, Medical Affairs, and Product Development.

 Principle Responsibilities:

• Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements
• Provide critical evaluation and review of clinical documents to support successful execution of regulatory objectives; proactively identify potential risks and develop implement mitigation strategies
• Interact with and support the Azurity Clinical Development and Medial Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input
• Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy
• Demonstrate knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics
• Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings
• Mentor, develop and act as a trusted advisor to coach members of the regulatory team regarding clinical strategy and writing; this position may or may not have direct reports

CORE Responsibilities

• Authoring, preparation and/or review of relevant clinical sections of regulatory applications such as INDs, NDAs, BLAs, including ISS and ISE, initial pediatric study plans, waivers, clinical and non-clinical sections
• Assessment of regulatory and critical clinical approval factors including but not limited to PK, PREA and other post-marketing safety studies
• Evaluation and determination of regulatory pathways within relevant therapeutic areas to provide insight into potential development opportunities to support and build the Azurity R&D pipeline
• Evaluation and analysis of available literature for the development of bridging strategies required to support 505(b)2)NDA submissions
• Authoring, preparation and/or review of sections of various FDA communications including, but not limited to Information Requests, Priority Review and Orphan Drug Designation requests
• Preparation and/or review of Agency meeting documents including meeting requests and briefing documents; lead FDA meetings/interactions regarding regulatory clinical discussions
• Authoring, preparation and/or review of clinical and nonclinical sections of drug product labeling
• Represent Regulatory Affairs at cross-functional team interactions to provide clinical strategic input
• Provide strategic clinical regulatory support for due diligence projects across various therapeutic areas and dosage strengths

Qualifications and Education Requirements

• 10+ years of pharmaceutical industry experience within Regulatory Affairs, strong scientific and regulatory background
• Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs
• Experience leading teams, coaching, and fostering a culture of efficiency and teamwork
• Ability to adapt to rapidly changing environments and circumstances, requiring a sense of urgency while ensuring that all cGMP and regulatory requirements are met
• Strong communication skills (written and verbal) demonstrated ability to express complex information clearly and concisely
• Bachelor’s degree in a scientific discipline or other closely related discipline is required; advanced degree preferred (MS, PharmD, PhD)

#LI-Hybrid
#LI-Full-time

Head of Statistics

Overview

NoviSci is a data science organization with a dual mission: 1) developing best-in-class software to support the generation of RWE and 2) executing high-impact, tech-enabled scientific consulting and research.

We are seeking a Head of Statistics who will own the statistical functional area- serving as the center of excellence for statistical rigor, methodology, methods standardization, and professional development across the organization. This is a hands-on leadership role for a methodologist who wants to build: building a team, building methods, and building the statistical backbone of real-world evidence software.

You will work shoulder-to-shoulder with the Head of Science, Product, Engineering, and Statistical Software Development, translating advanced causal inference and epidemiologic methods into robust software requirements, clear APIs, and scalable analytical tools. If you enjoy making hard statistical problems accessible, and care deeply about scientific credibility, this role is for you.

Statistical leadership & strategy

• In collaboration with the Head of Statistical Software Development, define and execute the statistical methods roadmap across products and services
• Serve as the functional center of excellence for statistical rigor, methods standardization, code reproducibility, and adoption of advanced causal inference and epidemiologic methods for real-world data
• Lead the development and implementation of causal inference, advanced epidemiologic, and statistical methods for real-world evidence generation, ensuring scientific rigor, transparency, and reproducibility
• Guide the design of longitudinal and observational study workflows, including uncertainty quantification and sensitivity analyses
• Represent NoviSci’s statistical perspective with external partners, clients, collaborators, and at scientific venues as a subject-matter expert

Product partnership (requirements, architecture, APIs)

• Collaborate with Product, Statistical Software Development, and Engineering to:
• Translate statistical and methodological needs into product requirements and roadmaps
• Advise on high-level system and architecture decisions
• Co-design API specifications (inputs/outputs, parameterization, defaults, error handling, diagnostics) and review PRDs/tech specs for statistical fidelity
• Provide reference implementations and simulation harnesses used as ground truth for verification; help design CI checks and validation datasets
• Establish documentation standards for methods notes, assumptions, and user-facing guidance

High-value scientific delivery

• Serve as a senior statistical contributor on select research pods, providing high-level expertise, validating analyses, and pioneering new methods
• Architect statistical designs for causal estimation of complex interventions under confounding, missingness, and dependent censoring
• Develop and review statistical analysis plans (SAPs), code, figures, and outputs for validity, reproducibility, and regulatory readiness
• Support quality and compliance processes in partnership with the Head of Operations, ensuring analysis validation, audit trails, and reproducibility standards are met

Thought partnership for clients

• Act as a senior statistical advisor to client teams (HEOR, Med Affairs, Epi); help mature their internal evidence pipelines and governance
• Evaluate statistical methodology choices for complex study designs, including distributed and federated analyses
• Guide clients on methods choices for regulatory submissions and HTA assessments

Team building & mentorship

• Serve as functional manager for all statisticians: hire, mentor, train, and conduct performance reviews
• Develop and enforce standards and SOPs for statistical analysis, code reproducibility, and methods adoption across the statistics group
• Foster a rigorous, supportive, and learning-oriented culture within the statistics functional group
• Uplevel engineers and PMs on statistical, advanced epidemiologic methods, including causal inference; uplevel statisticians on software craft (versioning, testing, CI/CD, profiling)

Required background

• PhD (or equivalent) in Biostatistics, Statistics, Epidemiology, or a related quantitative field
• 4+ years of post-doctoral experience spanning causal inference, advanced epidemiologic methods, statistical software development, and real-world data (claims, EHR, registries)
• Demonstrated track record of leading complex observational studies through publication and/or regulatory use
• Deep, hands-on expertise in causal inference and advanced epidemiologic methods for real-world data, including:
• Target trial emulation
• IP weighted estimators for confounding, missingness, and censoring
• Clone-censor-weighted estimation of dynamic treatment regimens
• Marginal structural models (MSMs), IPTW, and IPCW
• Uncertainty quantification and sensitivity analysis
• Proven ability to translate statistical and methodological requirements into product requirements, architecture trade-offs, and API designs in close partnership with engineering
• Strong experience with R, including package development, testing, and performance profiling
• Experience collaborating closely with software engineers in a production or near-production environment
• Evidence of thought leadership (publications, invited talks, open-source contributions, or methods papers)

Nice-to-have background

• Experience designing statistical APIs or platforms used by external customers
• Familiarity with regulatory expectations for RWE (e.g., FDA, EMA guidance on real-world evidence)
• Experience with CMS/Medicaid data governance and multi-source linkage/tokenization
• Prior experience managing or mentoring senior statisticians or data scientists
• Experience working in a fast-paced, product-driven or startup environment
• Comfort with protocol/report generators and figure/table QA pipelines (e.g., Quarto/R Markdown)
• Fluency with AI/ML coding tools (e.g., GitHub Copilot, Cursor) and comfort incorporating them into statistical programming and reproducible research workflows

If you’re excited to advance the science of real-world evidence in an environment where statistical rigor directly shapes both client impact and software innovation, NoviSci is the place for you. We’re building something important together, and we’d love for you to be a part of it.

What We Offer You

• Comprehensive health, dental, and vision coverage for you and your family
• 401(k) with company match
• Generous PTO and company holidays
• Paid parental leave
• Hybrid role: Located in Research Triangle Park, North Carolina