Data Standards Lead — CDISC & Regulatory Submissions
BioSpace
BioSpace is seeking an experienced professional to lead a group of data standards experts in developing and maintaining data standards for regulatory submissions. The role involves extensive knowledge of CDISC standards and compliance with industry regulations. The successful candidate will have over 12 years of clinical research experience and expert knowledge in areas such as SDTM and ADaM. The position requires strong communication skills and a commitment to mentoring peers. #J-18808-Ljbffr BioSpace
- ...is seeking an Associate Director - Data Standards to lead and manage a team focused on... ...role requires extensive knowledge of CDISC standards and regulatory compliance. The successful candidate... ...standards policies, ensuring high-quality submissions and effective communication across...Regulatory
$165.1k - $306.5k
...Product Development Data Sciences (PDD)... ...analyses, early regulatory engagements, and... ...Data Management TA Lead in Early Development... ..., and limited standardization, driving fit-for-... ...strong expertise in CDISC standards,... ...phase regulatory submissions (e.g., IND, CTA)...RegulatoryLocal areaRelocation packageFlexible hours$141.5k - $268.5k
Associate Director - Data Standards (Hybrid) Full-time Salary Min:... ...AbbVie, please visit us at Lead, manage and develop a group... ...from data collection to regulatory submission. Govern change control, publication... ...depth understanding of all CDISC guidance documents and...RegulatoryFull timeLocal area- ...The Manager, Clinical Data and Reporting Standards (CDARS) proactively... ...’s conformance to CDISC standards and industry... ...manner that support regulatory requirements to... ...for both FDA and PMDA submissions Consult on conformance... ...Experience leading development of standards...RegulatoryFull timeLocal area
- AbbVie is seeking a CDSO Data Strategy Lead to own all data-related start-up deliverables from protocol development through system... .... The role partners across study teams, drives data standards, and ensures regulatory adherence while optimizing processes and delivering...Regulatory
$48 - $53.68 per hour
...Professional Consulting BEPC is actively looking for a Data Analytics Lead in South San Francisco, CA 1 year contract with... ..., tables, and analyses based on clinical and regulatory requirements. ● Develop and maintain standard macros, reusable functions, and tools to improve...RegulatoryContract workTemporary work$260k - $275k
...the Senior Director, Clinical Data Management will be... ...support decision milestones and regulatory requirements. The qualified... ...management plans (DMPs), establish standards (CDISC/SDTM), and oversee EDC... ...experience with Regulatory submissions (IND/NDA/MAA). Adaptability...RegulatoryTemporary workWork at officeLocal area2 days per week3 days per week$180k - $200k
...We are seeking a Data Science leader within... ...high-quality, submission-ready deliverables... ...clinical development, regulatory submissions,... ...exploratory analytics and CDISC-based submission... ..., and company standards (e.g., CDISC, GxP,... ...Senior Manager: Lead data science activities...RegulatoryRemote work- Acadia Pharmaceuticals is seeking an Associate Director for Regulatory Affairs Project Planning & Coordination. This role involves developing... ...regulatory strategy execution, and overseeing regulatory submissions both pre- and post-approval. Candidates should have a minimum...RegulatoryWork at office
$235k - $285k
Septerna is seeking a Director/Senior Director of Regulatory Affairs in South San Francisco. This role involves leading regulatory strategy for clinical programs and managing submissions to health authorities. The ideal candidate will have over 10 years of experience in...Regulatory- Calico Life Sciences is looking for a Regulatory Director in South San Francisco to develop and implement innovative regulatory strategies... ...collaboration with various teams, overseeing regulatory submissions, and guiding development programs. The ideal candidate will have...Regulatory
- ...future of work. We partner with leading AI labs and enterprises to... ...About the role As Healthcare Data Partnerships Lead, you'll build... ...smooth data integration and regulatory compliance (HIPAA, de-... ...landscape: EHR vendors, data standards (FHIR, HL7), HIPAA compliance...Regulatory
- Kardigan is seeking an Executive Director, Data Strategy, AI & Collaboration in South San Francisco. This pivotal role involves leading data and AI initiatives, implementing... ...governance, and a strong understanding of regulatory compliance in life sciences. Competitive...Regulatory
$150k - $185k
...Therapeutics is seeking a Senior Specialist in Clinical Regulatory Affairs to support the planning and delivery of clinical submissions globally. This role will collaborate with... ...teams, ensuring compliance with regulatory standards and effective dossier management. Ideal...Regulatory- ...Responsibilities: Lead the data quality evaluation by investigating all clinical... ...of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including... ...preparation of data package for regulatory submission Represent data management for...RegulatoryFor contractors
$244k - $305k
...Director of Clinical Data Management... ...operational execution, and regulatory compliance to... ...responsibilities include leading and managing data... ...meet regulatory standards. Required Skills,... ...and regulatory submissions (FDA, EMA). In‑depth... ..., Medidata Rave), CDISC standards, and...RegulatoryContract work- TRexBio in South San Francisco, CA is seeking a Senior Director, Clinical Data Management to lead data management programs, define CDISC/SDTM standards, and oversee EDC builds for regulatory milestones. You will manage CROs, ensure ICH/GCP compliance, collaborate across...Regulatory
$219k - $273.7k
...Position Summary The Sr. Director, Data Management is a key... ...function. This individual will lead the design, implementation,... ...implementation of Data Management standards, processes, SOPs, and... ...datasets supporting analysis, regulatory submissions, and health authority...RegulatoryContract workWork at officeLocal areaRemote workNight shift3 days per week$136.9k - $254.2k
...within Product Development Data Science and Analytics (... ...pipeline and promote regulatory success - ultimately bringing... ...-making and regulatory submissions. You independently lead statistical input into... .../or R and familiar with CDISC standards You are able to work...RegulatoryLocal areaRelocation package$220.6k - $275.7k
...The Senior Director, Regulatory Operations provides strategic... ...overseeing electronic submissions, regulatory... ...Primary Responsibilities Lead and scale the global Regulatory... ...and global regulatory standards. Drive evaluation,... ..., including eCTD, CDISC, and SEND, and lead adoption...RegulatoryWork at officeLocal areaRemote workWorldwideNight shift3 days per week- ...Francisco, California seeks a Principal Trial Manager (PTM) to lead data management initiatives and ensure high-quality, compliant... ...will collaborate with trial managers, manage risk, and apply regulatory expertise in a hybrid work setting with travel requirements....Regulatory
$225k - $330k
...computational chemistry, and data integration to design... ..., interpretations, regulatory submissions (NDA, MAA and JNDA)... ...(SAP) and develop standardized well‑presented mock‑... ...specifications Coordinate and lead team review and... ...knowledge of CDISC submission requirements...RegulatoryWorldwide- ...Biotechnology is seeking a Senior Regulatory Writer (Temporary) to support regulatory submissions writing across programs. You... ...collaborate with senior management and leads, reporting to the Senior... ...to ICH guidelines and internal standards. Experience in biotech...RegulatoryTemporary work
- ...Pangaea Data, based in South San Francisco, is seeking... ...a Quality Assurance & Regulatory Affairs Specialist to build and lead regulatory and quality foundations... ..., prepare regulatory submissions, and ensure quality... ...of relevant standards. You will thrive in a collaborative...Regulatory
$269k - $340k
...The Executive Director, Data Strategy, AI &... ...Establish enterprise‑wide data standards, ontologies, master data... ..., and other applicable regulatory frameworks. Partner... ...Strategy & Implementation Lead the development and... ...clinical data standards (CDISC, SDTM, ADaM) and integration...RegulatoryContract work$135k - $150k
Jade Biosciences is looking for a Regulatory Affairs Manager to support the execution of regulatory strategies in a remote position. Responsibilities include managing submissions and ensuring compliance with global regulations. The ideal candidate will have 5-8+ years...RegulatoryRemote job$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco, responsible for leading regulatory strategies for drug approvals and submissions. Candidates should have extensive experience in Regulatory Affairs CMC within the biotech or pharmaceutical industry and be...RegulatoryRemote job$250k - $300k
Socure is seeking a seasoned professional to lead its research agenda and drive fraud analytics. In this role, you'll work with one... ...of the most consequential datasets globally, bridging external regulatory changes with internal models. With responsibilities ranging from...Regulatory- EPM Scientific is seeking a Senior Regulatory professional in the San Francisco Bay Area. This... ...treatments for rare diseases. You will lead regulatory initiatives and direct... ...and a proven track record of NDA and BLA submissions. A competitive compensation package is offered...Regulatory
$200k - $300k
...a Product Counsel to serve as the primary legal advisor on privacy matters. You will ensure that innovative practices align with regulatory compliance across global privacy laws, including GDPR and CCPA. Ideal candidates have a JD degree, at least 5-7 years of relevant...Regulatory
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