Clinical Data & Evidence Analysis Lead Job at SRG

Confirmed Clinical Data Analyst

We are looking for a Confirmed Clinical Data Analyst / Biostatistician to conduc...

Location

France , Paris

Salary:

50000.00 - 55000.00 EUR / Year

Implicity

Expiration Date

Until further notice

Requirements

Master's degree in Biostatistics, Statistics, Data Science, or related field (Ph.D. preferred)
Proven experience in Real-World Evidence (RWE) and Advanced Survival Analysis
Proven expertise in working with large-scale administrative claims databases, specifically the French SNDS/PMSI or similar national health data systems
Strong command of survival analysis and causal inference methodologies, with expertise in longitudinal modeling and complex weighting schemes to address selection and confounding biases
Experience in managing complex inclusion/exclusion criteria and mitigating common observational study biases
Strong command of longitudinal data modeling and causal inference techniques to address selection and confounding biases
Ability to design and draft formal Statistical Analysis Plans (SAP) and Statistical Analysis Reports (SAR)
Expert-level skills in SQL and R or Python for advanced statistical computing
Advanced understanding of data manipulation and the ability to define and implement complex inclusion/exclusion criteria
Strong sense of responsibility and rigor in task follow-up, with a proven ability to meet delivery commitments and deadlines

Job Responsibility

Lead the end-to-end biostatistical process, from initial study design and SAP authoring to final SAR reporting
Execute robust statistical analyses on longitudinal datasets, ensuring appropriate methodologies are used to mitigate common observational study biases
Evaluate clinical and healthcare resource utilization metrics to support scientific evidence generation
Provide the statistical foundation for peer-reviewed publications and high-impact international congress submissions

What we offer

Health care plan: Alan (50% employer)
Luncheon voucher: 9€ (50% employer)
Transport: 50% of your pass OR sustainable mobility pass
Eligible for stock option (BSPCEs) according to the company's existing rules

Fulltime

Head of Pre-Clinical & Chemical Analysis

Coloplast is strengthening its R&D organization with a Centre of Excellence (CoE...

Location

Denmark , Humlebæk

Salary:

Not provided

Coloplast

Expiration Date

Until further notice

Requirements

Experience leading and developing expert teams within pre-clinical, chemical analysis, materials science, or related disciplines
A track record of developing and implementing departmental strategies
Strong scientific credibility and curiosity, with the ability to connect biology, chemistry, materials, and device performance in relevant biological environments
Understanding of medical device development and how pre-clinical and analytical evidence supports regulatory submissions
A collaborative mindset and strong motivation to make it easier for others to do great work
Ability to navigate a large, matrixed organisations
Professional proficiency in English

Job Responsibility

Lead and develop a team of 13 scientists across pre-clinical and chemical analysis, building capabilities for both current delivery and future needs
Set the long-term direction for the department, ensuring methods, models, and infrastructure support R&D's strategic ambitions and an efficient evidence-generation roadmap
Integrate the department's agenda into broader stakeholder strategies by aligning priorities, roadmaps, and decision forums across R&D and relevant functions
Plan and prioritise resources, budget, and external partnerships to deliver high-quality results to project timelines across the R&D portfolio
Drive scientific and technical excellence through continuous improvement of test methods, pre-clinical models, and analytical approaches across the biology-chemistry-materials interface
Ensure compliance with applicable regulatory and quality requirements, including design-control ready documentation and robust reporting of data, results, and conclusions
Build and leverage strong internal and external scientific networks to bring in new knowledge and strengthen decision-making

Fulltime

Senior Manager, Evidence Generation Lead

The medical Director, evidence generation is responsible for supporting strategi...

Location

Belgium , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum of 7+ years of experience in evidence generation, clinical development, HEOR, or a related field, with at least 5 years of experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research
Proven track record of developing and implementing integrated evidence generation plans in the pharmaceutical or biotechnology industry
Experience in design, conduct and oversight of real-world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication
Solid understanding of the cross functional drug development lifecycle and processes (Business Development, clinical trial design, conduct, & endpoint selection, Clinical Operations, Data Management, Biostatistics, and Regulatory)
Demonstrated expertise and experience working with methods for evidence generation using primary and secondary data sources, knowledge of common issues and challenges of implementation, and track-record of successful publications
Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
Ability to explain strengths and limitations of clinical practice datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing pharmacoepidemiology study designs
Ability to work successfully in a matrix and quick paced environment
Ability to multitask priorities to align with program objectives

Job Responsibility

Collaborate with cross-functional colleagues to Lead the development and execution of Medical evidence generation strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources ensuring alignment with corporate goals, regional needs, and therapeutic priorities
Oversee the Design and implementation of Integrated Evidence Generation Plans (IEGPs) that incorporate clinical, real-world, and economic data to support product positioning and value demonstration
Scope RWE studies (Regional/National/Academic/Patient/Vendor), selection of new or existing academic (can include: ISR/lIS/NIS)/non-governmental registries (retrospective/prospective), management across various phases from start up, maintenance to final deliverables
Translate (early) trial efficacy to real-world comparative effectiveness as part of early and late phase study planning, identification of subpopulations, and for potential risk-sharing purposes
Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits and/or risks potentially associated with Alfasigma products
Project management oversight – ensuring effective design, initiation and implementation of real world evidence studies, while ensuring effective study protocols and plans, managing budget and milestone tracking, and where appropriate contracting with partner organizations
keep abreast on new data and developments in the field, key publications of interest, research methodologies and regulatory standards across the EU and New Markets regions and proactively address HOR strategy changes in collaboration with global and regional teams in anticipation of any trends
Review and provide relevant RWE/HOR inputs to statistical analysis plans and analysis outputs
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Establish metrics to evaluate the effectiveness and impact of evidence generation activities on corporate and product-specific objectives

What we offer

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development

Medical Director, Global Evidence Generation Lead

The medical Director, evidence generation is responsible for supporting strategi...

Location

Belgium , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum of 7+ years of experience in evidence generation, clinical development, HEOR, or a related field
At least 5 years of experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research
Proven track record of developing and implementing integrated evidence generation plans in the pharmaceutical or biotechnology industry
Experience in design, conduct and oversight of real-world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication
Solid understanding of the cross functional drug development lifecycle and processes (Business Development, clinical trial design, conduct, & endpoint selection, Clinical Operations, Data Management, Biostatistics, and Regulatory)
Demonstrated expertise and experience working with methods for evidence generation using primary and secondary data sources, knowledge of common issues and challenges of implementation, and track-record of successful publications
Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
Ability to explain strengths and limitations of clinical practice datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing pharmacoepidemiology study designs
Ability to work successfully in a matrix and quick paced environment

Job Responsibility

Collaborate with cross-functional colleagues to Lead the development and execution of Medical evidence generation strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources ensuring alignment with corporate goals, regional needs, and therapeutic priorities
Oversee the Design and implementation of Integrated Evidence Generation Plans (IEGPs) that incorporate clinical, real-world, and economic data to support product positioning and value demonstration
Scope RWE studies (Regional/National/Academic/Patient/Vendor), selection of new or existing academic (can include: ISR/lIS/NIS)/non-governmental registries (retrospective/prospective), management across various phases from start up, maintenance to final deliverables
Translate (early) trial efficacy to real-world comparative effectiveness as part of early and late phase study planning, identification of subpopulations, and for potential risk-sharing purposes
Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits and/or risks potentially associated with Alfasigma products
Project management oversight – ensuring effective design, initiation and implementation of real world evidence studies, while ensuring effective study protocols and plans, managing budget and milestone tracking, and where appropriate contracting with partner organizations
keep abreast on new data and developments in the field, key publications of interest, research methodologies and regulatory standards across the EU and New Markets regions and proactively address HOR strategy changes in collaboration with global and regional teams in anticipation of any trends
Review and provide relevant RWE/HOR inputs to statistical analysis plans and analysis outputs
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Establish metrics to evaluate the effectiveness and impact of evidence generation activities on corporate and product-specific objectives

What we offer

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development

Manager, Statistical Data Sciences Lead

A highly productive, independent statistical data sciences lead ensuring excelle...

Location

Greece , Thessaloniki Pylaia

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s (preferred) Degree in Statistics, Data Sciences, Biological Sciences, IT, or related field
At least 5 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency
Clinical trials expertise with a thorough understanding of data operations required for the reporting of clinical trial data
Good understanding of ICH and Regulatory Guidelines including submission requirements and data conformance (e.g., Pinnacle21)
Statistical Programming and SAS, R, or Python hands-on experience
Familiarity with R packages, Shiny Apps, Markdown reports and other associated data science and data analytics tools and AI/ML highly desired
Experience with Real World Evidence and other big data sources and associated standards (e.g.OMOP, JSON, ODHSI ) in support of regulatory filings desired
Active participation in relevant industry groups (e.g., PHUSE, CDISC, IHD)
Routine problem solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situations
Thorough understanding of clinical data and relevant data standards (e.g., CDISC)

Job Responsibility

Ensuring excellence in the delivery of analysis ready datasets, analysis results, and displays such as tables, listings, and figures to advance research, development, and commercialization of the Pfizer portfolio following Pfizer SOPs and processes
Ensuring adherence to high quality statistical data sciences principles, processes and techniques in the production of clinical reports
Being the statistical data sciences point of contact at the study level, and supporting at the asset/submission level
Delivering through combination of oversight of in-house statistical data scientists / vendors / offshore support as well as through hands on application of statistical data sciences techniques
Working with department leadership and project teams to establish strategy, timelines, and resourcing of deliverables for their study(ies)
Being accountable for the quality and timely delivery of datasets, analysis results and displays required for their clinical study reports as well as other asset level deliverables
Ensuring appropriate documentation across the lifespan of the study for deliverables and verifying proper Trial Master File filings
Ensuring planning is in place for all deliverables including consideration of special data types and downstream uses of data
Working with statisticians, statistical data science resources and other colleagues to ensure clear specifications for deliverables are in place
Being knowledgeable in core safety standards as well as Therapeutic Area standards or Industry data standards for unique data types

What we offer

Work life harmony
Trusting, flexible workplace culture
Disability inclusion
Equal employment opportunities

Fulltime

New

Medical Director, Pulmonary

Join the team transforming care for people with immune challenges, rare diseases...

Location

United States , Cambridge; Morristown

Salary:

206250.00 - 343750.00 USD / Year

Sanofi

Expiration Date

September 28, 2026

Requirements

Advance degree in life sciences or pharmaceutical sciences (PhD, PharmD, PA, NP or MD with relevant experience)
Minimum 5 years of relevant experience in Medical Affairs
Strong track record in developing and executing medical strategies in the US
Clinical or medical affairs experience in Pulmonary and/or Immunology strongly preferred
Industry experience in Medical Affairs and/or Clinical Development, with significant experience in Medical Affairs Launch and Life Cycle Management activities
High degree of knowledge of relevant healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends to accurately identify key issues and develop strategies
Sound scientific and clinical judgment, including an in-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale
In-depth understanding of how to conceptualize, design, and conduct clinical trials. Experience in clinical trial design and execution preferred
Ability to disrupt status quo with innovation while remaining pragmatic and focused on priorities
ability to translate innovative strategies or solutions into actionable plans

Job Responsibility

Develop strategy and tactics for an integrated Medical Plan (Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research including Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned the respective therapeutic area products
Execute the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities and deliverables
Communicate the details and Progress of the Medical Plan to Management, the Core Team, and all parties responsible for execution
Provide relevant data evidence to ensure that strategy is clearly defined and consistent with clinical development and commercial strategic objectives
Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans
Provide impactful medical strategy and expertise to Clinical, Commercial, Market Access, and Regulatory partners
Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of the respective therapeutic area products, cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities
Provide medical leadership and expertise to sales, marketing, legal, and regulatory functions for marketed products and drugs in development
Pro-actively provide scientific guidance and collaborate with field team, marketing, HEVA, Market Access, and sales teams
Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans, managing resources and budgets.

What we offer

High-quality healthcare
Prevention and wellness programs
At least 14 weeks gender-neutral parental leave

Fulltime

Clinical Specialist, Quality Management & Training

The Clinical Compliance & Quality Specialist is responsible for ensuring regulat...

Location

United States , California

Salary:

60600.00 - 91000.00 USD / Year

Personify Health

Expiration Date

Until further notice

Requirements

Holds an active unrestricted Registered Nursing License Required
May require additional licensure
Bachelor’s Degree preferred
3-5 years UR, CM, DM experience required
Managed care experience preferred
CPHQ and/or CCM certification preferred
3 years of experience leading, mentoring, and training staff, with a strong ability to teach diverse audiences and adapt methods to varying learning needs
Completed advanced coursework in teaching and/or mentoring
In-depth knowledge of state and federal regulations, including HIPAA, CMS, NCQA, and URAC
Ability to interpret and apply evidence-based guidelines and accreditation standards to clinical operations

Job Responsibility

Ensure compliance with state, federal, and accreditation standards, including ERISA, NCQA, URAC, and HIPAA
Conduct internal and external audits of clinical programs, prepare detailed reports, participate in case file preparation and mark-up for audits
Monitor clinical trial activities to ensure protocol adherence and regulatory alignment
Identify and manage risks related to clinical quality and compliance, review and approve Standard Operating Procedures (SOPs), and collaborate with cross-functional teams to resolve quality issues and implement improvements
Train clinical staff on regulatory requirements, quality standards, and department objectives
Develop and maintain evidence-based training materials and software tools, and deliver training in various modalities (classroom, virtual, self-learning, and one-on-one) to adult learners with different levels of experience
Track and report training activities and employee progress, updating department leadership on staff who are not meeting expectations
Participate in quality audit programs and conduct monthly sample quality analysis audits to identify gaps and training opportunities
Support corrective action plans as directed by management and provide comprehensive follow-up
Maintain current knowledge of industry regulations, accreditation standards, and evidence-based practices to support staff education

What we offer

Competitive base salary and benefits effective day one
Comprehensive medical and dental through our own health solutions (yes, we use what we build)
Unlimited PTO—rest and recharge time is non-negotiable
Mental health support, retirement planning, and financial protection
Professional development with clear career progression and learning budgets
Mission-driven culture where diverse perspectives drive real impact on people's health

Fulltime

Consultant, Advanced Analytics: Meta-Analysis (HTA Statistician)

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

A Master's or Doctoral-level degree in applied statistics, health economics, and related quantitative fields
A minimum of 3 years of hands-on experience working in the pharmaceutical industry, a consultancy, Access/HTA/reimbursement agency, or academic institution (pharma affiliate experience is a plus)
Demonstrate in-depth knowledge of Access and HTA, clinical research and development methods, and international payer evidence requirements
Skilled in research design and statistical methods, such as Generalized Linear Models, Survival analysis, Network Meta-Analysis, and Bayesian statistics and are proficient in R and GitLab (experience with SAS, Python, WinBUGS, JAGS, or other relevant statistical software is a plus)
Strong strategic, collaboration, and communication skills, strong organization, planning, and prioritization skills with an ability to meet tight deadlines, and strong written and verbal communication skills in English

Job Responsibility

Provide expert input on the design of clinical development programs to ensure Access/HTA evidence needs are considered within global development and commercialization strategies
Identify evidence gaps, possible data sources, and design and implement robust evidence-generation plans
Ensure Access/HTA evidentiary activities are strategically aligned with other functions within Global Access and the wider organization (affiliates, Product Development, commercial, etc.)
Plan and conduct statistical analyses of clinical trials and other relevant data sources and develop supporting technical documentation for statistical analyses and economic models
Interpret and communicate the findings of analyses and work closely with affiliates to incorporate global statistical and health economics input into their local reimbursement applications
Lead or contribute to cross-functional teams within a matrix structure and actively contribute to the development of methodologies and continuous improvement within the Evidence Chapter
Keep up to date with the changing Access/HTA landscape and academic research to ensure current access trends and methodologies are incorporated into evidentiary plans and build relationships with relevant external statistics, health economics, Access/HTA, and policy experts
Ensuring that all assigned projects are being conducted in an efficient manner and that quality and client satisfaction is maximized at all times
Guide the Senior associates and Associates in their daily duties and to flag any areas of acute training needs to their line managers
Maintaining client relationships on their projects

What we offer

Flexible work arrangements (remote work)

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Clinical Data & Evidence Analysis Lead

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