CMC Statistics Director — Lead Data-Driven Biotech Quality
Vertex Pharmaceuticals
Vertex Pharmaceuticals seeks a CMC Statistics Director (Scientific Fellow) to lead statistical sciences across the product lifecycle, partnering with Development, MSAT, Quality, Regulatory Affairs, and Data & Digital teams to drive data-driven decisions and improve product quality and process robustness. This role establishes the CMC Statistics Center of Excellence, defines standards, governance, and best practices, and leads advanced analytics, DOE, and process monitoring to support Vertex's #J-18808-Ljbffr Vertex Pharmaceuticals
- ...Pharmaceuticals Incorporated seeks a CMC Statistics Director (Scientific Fellow) to lead statistical science across the product... ...and partner with Development, MSAT, Quality, Regulatory, and Data & Digital teams to enable data-driven decisions. The role emphasizes scientific...Quality
- ...among others. Our lead oligonucleotide programs... ...multiple clinical data readouts as we... ...research and driven to advance drug development... ...foundation in statistics and clinical... ...deliverables, ensuring high quality and timely... ...analysis within the biotech/pharmaceutical industry...QualityLong term contractFull timeContract workPart timeLocal areaRemote work
$240k - $340k
...models, which leads to better drug... ...design with in vivo data at scale. You... ...deliver data-driven recommendations... ...without compromising quality or rigor. Build... ...for Senior Director level Drug-... ..., clinical and CMC considerations... ...project teams in biotech or pharma Bioanalytical...QualityFlexible hours$136.51k - $204.77k
...Job Title: Associate Director, CMC Lead Introduction to role: Are you ready to lead... ...guide and contribute to authoring high-quality documentation and data packages for IND/IMPD submissions.... ...selection through clear, data-driven risk/benefit assessments. Target...QualityHourly payTemporary work$122.25k - $176.58k
Job Title: CMC Demand & Supply LeaderLocation: Framingham... ...to Regulatory and Quality requirements. This role... ...About Sanofi:We’re an R&D-driven, AI-powered biopharma company... ...budget definition.Co-lead Demand & Supply Sub Team... ...)Knowledge of data analytics and forecastingProject...QualityFull time$150k - $168k
The Director of Platform Data Operations owns the shared data language... ...created, owns data quality across migrations, and... ...no clean source. Lead remediation of legacy... ...within an acquisition-driven or multi-entity environment... ..., and maintain statistics on applicants. Accommodation...QualityWork at officeLocal area$168k - $252k
...are seeking a highly technical Lead Product Manager to set the... ...strategy, and execution for our Data Ingestion Platform. This is a... ...priorities based on outcomes.Champion Quality & Reliability: Drive... ...systems; experience with event-driven systems, high-volume ingestion...QualityTemporary work- ...for this position.Improves the quality and time-to-market of research... ...methods -- advanced econometrics and statistics (probabilities, linear regressions, and time series data analysis). Develops analytical... ...anomalies by generating data-driven insights using SQL and Python....QualityFull time
$154.5k - $202k
...is a tech and AI driven pharma company differentiated... ..., and biotechs to develop programs... ...About the Role As Lead Tech Recruiter,... ...technical talent for our data science,... ...business partner to directors, VPs, and CTOs, advising... ...raise the quality and speed of our process...QualityFull timeWork at officeLocal areaRelocation3 days per week- ...Boston area is seeking an R&D Recruiting Lead to serve as the senior recruiting partner... ...on talent strategy, and raise the overall quality of recruiting across the team. This hands... ...compensation and a collaborative, growth-driven environment. #J-18808-Ljbffr Socket.devQuality
- CRISPR Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a portfolio of gene-based medicines... ..., you will manage complex CMC topics, prepare high-quality submissions, and guide global teams through INDs, CTAs,...QualityContract workWorldwide
- Vertex Pharmaceuticals is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness to drive inspection readiness and compliance for external sites. The role collaborates across functions and sites to maintain quality culture and address risks through...Quality
- ...seeking a Managing Consultant to lead pharma/biotech/medical device client... ...work plans, and ensure high-quality client deliverables. Travel... ...%-25% and you’ll work with Directors to advance project outcomes... ...in oncology strategy and data-driven decision making is essential...Quality
- ...Manager in Front Office Strategy Consulting within our Customer Analytics practice. You will lead data analysis, drive data-driven decision making, and mentor teams to deliver high-quality results. The role emphasizes ownership of projects, collaboration with client...Quality
$176.4k - $327.6k
...Associate Director, Clinical Data EngineeringAbout the role: Are... ...Associate Director to lead Clinical Data Engineering... ...making and enable AI-driven initiatives in... ...Data Management, Data Quality, Data Science, Data Strategy... ...), R (Programming Language), Statistical Analysis...QualityRemote work$202.5k - $337.5k
Global CMC Automation and Robotics Leader... ...manufacturing, fueled by data and digital... ...across CMC Build and lead a team of advanced... ...deployment Expertise in AI‑driven robotics and... ...including high‑quality healthcare, prevention... ...Seniority Level Director Employment Type Full...QualityFull timeLocal area- Rhythm Pharmaceuticals Inc. in Boston, MA seeks an experienced Regulatory CMC professional to drive high-quality regulatory chemistry, manufacturing, and controls deliverables. You will support global filing strategies, coordinate with Global Regulatory Affairs, Technical...Quality
- Beeline Medicines seeks a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets, including monoclonal antibodies... ...with Process Development, Analytical Sciences, Quality, and external CMOs to align with FDA/EMA expectations...Quality
- ...Manager in the Measurement & Analytics practice. The role involves leading data and analytic services to support clients' marketing efforts,... ...for professional growth and contribution to impactful, data-driven marketing campaigns. #J-18808-Ljbffr Allen & Gerritsen
- ETalent is seeking a Director of Data Management in Cambridge, MA. The successful candidate will oversee data management service capabilities and ensure adherence to quality standards and compliance with regulations. The role includes developing systems for service needs...Quality
- A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA...
- Jobtailor is seeking a data‑driven Site Feasibility Lead to manage end‑to‑end feasibility activities for clinical programs in a fast‑paced biotech environment. You will coordinate cross‑functional teams, design feasibility questionnaires in Veeva Clinical, and deliver insights...
- Hongene Biotech is seeking an Associate Director / Senior Manager in CMC Project Management in the Boston area. The role reports to the VP, Global Head of CMC & Regulatory and strengthens project management for oligonucleotide contract manufacturing services. Senior/AD...Contract work
$177k - $278.08k
...(GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...: You will be the GRA CMC Franchise Lead for TAK-079 Independently develops the regulatory... ..., Analytical Development, Production, Quality Assurance can be considered. Strong...QualityMinimum wageFull timeTemporary workLocal areaRemote workWorldwide- BMCHS in the Boston area is seeking a Director of Logistics Distribution to partner with hospital leadership... .... You will develop and monitor KPIs, drive data-driven inventory and forecasting plans, conduct audits, and lead supplier performance reviews with cross-...
$115k - $135k
829 Studios in Boston is seeking a Strategy Director to lead comprehensive marketing strategies and campaigns. This senior role demands a deep understanding of data-driven insights and customer segmentation, with responsibilities including orchestration of integrated solutions...Remote job- Klaviyos in Boston is seeking an on-site Data Ops professional to operate and extend our agentic GTM data quality pipeline, coordinating with offshore contractors to ensure reliability and throughput. You will tune detection rules, manage AI-assisted enrichment workflows...QualityFor contractors
- ...business strategy for cutting-edge biotech facilities that enable... ...standards, best practices, and quality benchmarks for life science... ...world-class biotech facilities.Lead design proposals for new labs... ...tools (BIM, Revit) and data-driven design approaches.Ability to...Quality
$139k - $186k
About This RoleThe lead of digital... ...marketing measurement and data science is... ...efforts, and make data-driven recommendations. The... ...agencies to develop statistical and machine... ...to detail, with a quality-focused mindset; aptitude... ...Skills:Biotech/pharma experience...QualityFull timeTemporary workLocal area$152k - $220k
As Associate Director, Data Engineering & Architecture at Biogen... ...(DMA) strategy, while leading design and delivery... ...management, data quality, lineage, and privacy... ...reporting, AI/ML, and data-driven business initiatives.... ...in Pharmaceutical or Biotech industry preferred. Experience...QualityFull timeTemporary workLocal area3 days per week
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