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Cmc Statistics Jobs in Washington (NOW HIRING)

Regulatory Affairs Director

Gaithersburg, MD · On-site

$162K - $213K/yr

... CMC, Labeling and members of the submission and execution team. Mentor and provide performance ... or statistical design. * Broad background of experience working in pharmaceutical business and ...

Director, Regulatory Affairs

Washington, DC

$169K - $224K/yr

Bachelor's degree in a scientific, engineering, or regulatory discipline (e.g., CMC); MS or PhD ... Knowledge and experience utilizing research evidence and providing statistical analysis is ...

Regulatory Affairs Director

Gaithersburg, MD

$162K - $213K/yr

... CMC, Labeling and members of the submission and execution team. Mentor and provide performance ... or statistical design. * Broad background of experience working in pharmaceutical business and ...

Regulatory Affairs Director

Gaithersburg, MD

$162K - $213K/yr

... CMC, Labeling and members of the submission and execution team. Mentor and provide performance ... or statistical design. * Broad background of experience working in pharmaceutical business and ...

Cmc Statistics information

What are the key skills and qualifications needed to thrive as a CMC (Chemistry, Manufacturing, and Controls) Statistician, and why are they important?

To thrive as a CMC Statistician, you need a strong background in statistics, pharmaceutical sciences, and regulatory guidelines, typically supported by an advanced degree in statistics or a related field. Proficiency with statistical software such as SAS, R, and familiarity with quality systems and ICH/FDA guidelines is essential. Attention to detail, problem-solving skills, and strong communication abilities help you effectively analyze complex data and collaborate with cross-functional teams. These skills are crucial for ensuring product quality, regulatory compliance, and the successful development and manufacturing of pharmaceuticals.

What is the difference between Cmc Statistics vs Data Analyst?

AspectCmc StatisticsData Analyst
Required CredentialsBachelor's in Statistics, Mathematics, or related field; often certifications in statistical softwareBachelor's in Data Science, Statistics, or related; sometimes certifications in data tools
Work EnvironmentResearch labs, pharmaceutical companies, or biotech firmsBusiness, finance, healthcare, or tech companies
Industry UsagePrimarily in pharmaceutical and biotech industries for clinical data analysisAcross various industries for interpreting data and supporting decision-making

While both roles involve data analysis, Cmc Statistics focuses on clinical and pharmaceutical data within biotech industries, requiring specialized knowledge of regulatory standards. Data Analysts work across diverse sectors, analyzing data to inform business strategies. Understanding these differences helps in choosing the right career path or job search focus.

What are CMC Statistics professionals and what do they do?

CMC Statistics professionals specialize in the application of statistical methods to Chemistry, Manufacturing, and Controls (CMC) activities within the pharmaceutical and biotechnology industries. Their work involves designing experiments, analyzing data, and ensuring product quality throughout the drug development and manufacturing process. They collaborate with scientists, engineers, and regulatory teams to support submissions to health authorities and maintain compliance with industry standards. By providing statistical expertise, CMC statisticians help optimize processes, validate analytical methods, and ensure consistency and safety of pharmaceutical products.

What are some typical challenges faced by professionals in CMC Statistics, and how can they be addressed?

Professionals in CMC Statistics often encounter challenges such as managing large and complex datasets, ensuring data integrity across multiple stages of drug development, and effectively communicating statistical findings to multidisciplinary teams. Staying current with regulatory requirements and adapting to evolving analytical methods are also key challenges. These can be addressed by using robust data management systems, fostering strong cross-functional collaboration, and participating in ongoing professional development to stay updated with industry trends and regulatory guidance.

What jobs make $1,000,000 a year?

In the field of CMC statistics, high-earning roles such as senior data scientists, quantitative analysts, or chief data officers can reach or exceed $1,000,000 annually, especially in large corporations or financial firms. These positions typically require advanced degrees, extensive experience, and expertise in statistical modeling, programming, and data analysis tools. Compensation often includes base salary, bonuses, and stock options.

What are the highest paying jobs in statistics?

High-paying jobs in statistics include roles such as data scientist, quantitative analyst, and statistical director, often requiring advanced degrees and expertise in programming, machine learning, and data analysis tools. These positions typically offer salaries above industry averages, especially in finance, technology, and consulting sectors.

What is a CMC statistician?

A CMC statistician specializes in statistical analysis related to Chemistry, Manufacturing, and Controls (CMC) processes in the pharmaceutical or biotech industries. They design experiments, analyze data, and ensure compliance with regulatory standards to support drug development and manufacturing. Proficiency in statistical tools like SAS or R and knowledge of regulatory guidelines are often required.

Are biostatisticians in high demand?

Biostatisticians are in high demand due to their essential role in clinical research, public health, and pharmaceutical industries. The field offers strong job growth prospects, often requiring proficiency in statistical software and a background in biology or medicine.
What cities in Washington are hiring for Cmc Statistics jobs? Cities in Washington with the most Cmc Statistics job openings:

Senior Director, Machine Learning & AI (BPD)

AstraZeneca

Gaithersburg, MD • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 8 days ago


AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

19th of 86 rated pharmaceutical


Job description

Role purpose
AstraZeneca's bold ambition is to be a pioneer in science, lead in our disease areas and transform patient outcomes - and by 2030, to deliver 20 new medicines and industry-leading growth. Biologics are central to that ambition, and Biopharmaceutical Development (BPD) is the R&D function that turns biologic candidates into medicines. BPD develops the cell lines, bioprocesses, formulations, devices and analytical methods needed to advance biologic medicines through clinical development and approval where they can improve the lives of patients. As the portfolio grows in scale and complexity, BPD is increasingly adopting a Predict-First CMC approach: FAIR data at source, greater use of modelling and digital twins, and AI-enabled tools that help scientists find knowledge, make decisions and create regulatory content more efficiently.
The Senior Director, Machine Learning & AI leads the ML & AI team within BPD: a multidisciplinary group of specialists spanning data science, AI and data engineering, and applied machine learning research. The role is accountable for translating BPD's Predict First ambition into a coherent AI strategy and portfolio roadmap that transforms emerging technologies and promising ideas into trusted, scalable capabilities that deliver measurable scientific and business value. The Senior Director defines the ML & AI strategy for BPD, owns delivery of the AI portfolio within the digital transformation roadmap, and serves as BPD's senior technical interface with Enterprise AI and R&D IT. The role is responsible for establishing a framework that rapidly tests and demonstrates value through proof-of-concepts (PoCs), accelerates adoption through iterative delivery, and enables the scaling of successful AI solutions across BPD.
In addition, the Senior Director partners closely with Robotics & Automation, Informatics, Digital Transformation, Enterprise AI, and R&D IT teams to identify opportunities where ML & AI can enhance scientific, operational, and business outcomes and to integrate AI capabilities into products, platforms, and workflows across BPD (e.g. Physical AI). The role provides strategic leadership on the data foundations required to enable AI at scale, including data architecture, governance, engineering, and platform capabilities, ensuring that high-quality, accessible, and trusted data can support advanced analytics, machine learning, and AI solutions across the enterprise.
Success in this role requires a balance of strategic leadership and technical credibility. The Senior Director will shape investment decisions, build organisational capability, drive adoption across BPD, influence senior stakeholders across BPD and the enterprise, and provide the technical judgement needed to guide delivery and manage risk.
Key accountabilities
Strategy and portfolio
  • Define and maintain BPD's multi-year ML&AI strategy, aligned with a Predict-First CMC organization, the BPD digital transformation roadmap and AZ's AI30 ambitions.

  • Be accountable for the BPD AI portfolio across the four pillars: AI Foundations & Platforms, Knowledge Management, Modelling & Digital Twins, and Submission & Report Authoring.

  • Set portfolio priorities across in-flight, self-funded and proposed initiatives, making clear, evidence-based recommendations on when to build, buy, partner, pause or stop.

Technical leadership
  • Provide senior technical oversight of model strategy, evaluation and deployment across predictive ML, mechanistic and hybrid models, protein sequence and structure models, knowledge graphs, RAG and agentic architectures.

  • Set practical engineering standards for the team, including reproducibility, model risk management, MLOps, evaluation frameworks and human-in-the-loop approaches for GxP-adjacent use cases.

  • Chair or lead technical review of the highest-risk or highest-value deliverables, ensuring decisions are well evidenced and risks are visible to the right governance forums.

Team leadership
  • Lead and develop a high-performing ML&AI team of data scientists and AI/data engineers, growing capability and reach through permanent hires, secondments, PDRAs and vendor partnerships.

  • Create the operating model, ownership and delivery discipline needed for a small specialist team to have enterprise-level impact.

  • Support AI training and culture change across BPD, helping scientists use AI well rather than simply use it more.

Cross-functional delivery
  • Work with modelling/AI, digitalization and robotics transformation leads to align investment, dependencies and delivery plans across AI, data and automation.

  • Partner with R&D IT so enterprise platforms meet BPD's scientific needs, and BPD requirements are visible in strategic platform roadmaps.

  • Serve as BPD's senior technical voice into Enterprise AI: adopt enterprise capability where it fits, escalate gaps, and shape shared offerings where BPD should not rebuild common capability

  • Work closely with CMC Statistics, Informatics & Software Engineering, and Robotics & Automation Development colleagues so that ML&AI outputs sit on sound statistical, software and laboratory foundations. Build Physical AI as an emerging BPD capability by partnering with Robotics & Automation, Informatics, Digital Transformation, Enterprise AI and R&D IT to connect ML&AI models, agents and decision-support tools with laboratory automation, instrumentation and closed-loop experimental workflows.

Governance, compliance and risk
  • Ensure BPD's AI work aligns with AZ AI governance, data governance, information security and GxP expectations, as well as emerging external regulatory guidance on AI in CMC.

  • Contribute to AZ's regulatory advocacy on AI in CMC where BPD's experience is directly relevant (e.g. via the CMC Strategy Board and PMF AI in CMC Working Group).

  • Be accountable for responsible-AI practice across the BPD portfolio, including model documentation, validation evidence, bias and robustness testing, and lifecycle management.

External innovation and partnerships
  • Work with the AI Partnerships Lead to bring useful external thinking into BPD through academic collaborations, consortia and vendor evaluations.

  • Represent BPD externally through selected publications, conferences and standards forums where this supports the strategy.

Stakeholder engagement
  • Brief digital transformation and BPD leadership on progress, value, trade-offs and risk, distinguishing clearly between proven capability, active pilots and speculative opportunities.

  • Act as a trusted advisor to BPD functional leaders on where AI can, and cannot, help them meet their objectives.

Qualifications and experience
Essential
  • Advanced degree, MSc or PhD, in a quantitative discipline such as computer science, machine learning, statistics, applied mathematics, physics, computational biology, chemical or biochemical engineering, or a closely related field. Typically, PhD plus 7 years' relevant experience, or MSc plus 10 years' relevant experience.

  • Track record of leading ML and AI teams that deliver production capability, not just prototypes, in regulated or scientifically demanding environments.

  • Strong technical judgement across modern ML and AI, including classical ML, deep learning, foundation models, LLMs, RAG, agentic AI, knowledge graphs, digital twins and MLOps. The expectation is not deep expertise in every area, but sufficient technical depth to guide architecture, challenge assumptions and make sound delivery decisions.

  • Experience shaping LLM, RAG or agent-based solutions from problem definition through architecture, evaluation and deployment, including retrieval design, grounding, human review, failure mode analysis and appropriate controls for scientific use.

  • Strong understanding of production ML and AI engineering, including reproducible development, version control, testing, CI/CD, containerized deployment, monitoring, model lifecycle management and operational support.

  • Experience establishing practical evaluation approaches for ML and AI systems, including benchmarks, test datasets, model performance measures, uncertainty, robustness, explainability and user feedback loops.

Desirable
  • Domain understanding of biologics CMC, bioprocess development, formulation, analytical development, manufacturing science or regulatory submissions.

  • Experience applying ML or AI to complex scientific, engineering or industrial problems, rather than only general business analytics or consumer-facing applications.

  • Familiarity with FAIR data principles, data product thinking, ontologies, controlled vocabularies and knowledge graphs applied to scientific data.

  • Experience with GxP-adjacent AI, model validation for regulated use, responsible AI governance, or contribution to regulatory advocacy on AI/ML.

  • Familiarity with enterprise search, graph-based retrieval, graph query approaches or semantic architectures that support knowledge management and reuse.

  • Familiarity with hybrid mechanistic-ML modelling, Bayesian methods, Gaussian Processes, active learning, Bayesian optimization or digital twins relevant to process development or manufacturing.

  • Experience scaling AI tools for use by non-technical scientific staff, including adoption, training, feedback and support models.

  • Peer-reviewed publications, patents, open-source contributions or visible external contributions in applied ML, AI or data science for life sciences.

What success looks like in the first 12-18 months
  • Measurable time saved on knowledge retrieval across BPD, supported by an agent architecture and evaluation framework the team is confident to scale.

  • At least one authoring pipeline moved from proof of concept into production use for a regulatory submission or comparability report.

  • A working digital twin capability for a prioritized unit operation, with a defensible modelling strategy for the rest of the roadmap.

  • An ML&AI team that is known - inside BPD and beyond - for high-quality delivery, clear technical judgement and honest communication about what AI can and cannot do.

  • BPD requirements reflected in enterprise roadmaps, delivery commitments and platform investment decisions.

Why AstraZeneca?
When we put unexpected teams in the same room, we unleash bold thinking with the power to encourage life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
The annual base pay for this position ranges from $203,213.60 - $304,820.40 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Are you ready to bring new insights and fresh thinking to the table? Fantastic! We have one seat available, and we hope it's yours. Apply today.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Date Posted
28-Jul-2026
Closing Date
06-Aug-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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