Lead Statistical Programmer - Submission Data Standards & QA
Merck & Co. Inc
HireLifeScience seeks an Associate Principal Statistical Programmer for SDS QM to oversee and improve submission data standards for global regulatory submissions. You will coach teams, liaise with FDA/EMEA/PMDA, and ensure data conformance and traceability across SDTM and ADaM deliverables. Key responsibilities include planning, coaching, and contributing to governance initiatives while guiding external vendors and internal stakeholders toward high-quality, timely deliverables. #J-18808-Ljbffr Merck & Co. Inc
$142.4k - $224.1k
...patients and global human health.The Associate Principal Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and... ..., and governance.Experience contributing to or leading Standards governance forums influencing cross-functional...DataFull timeFor contractorsLocal areaWorldwideFlexible hours- ...Principal Scientist role overseeing submission data standards quality management for regulatory drug... ...Pinnacle 21 Enterprise tool usage Lead SDTM version-up activities and participate... ...best practice forums Serve as statistical programming point of contact and...DataWorldwide
- ...and other regulatory submission deliverables. Create statistical analysis outputs to... ...in establishing standardized programming procedures... ...and coordinate and lead a statistical... ...mentor statistical programmers to provide input into... ...biostatisticians, data managers, medical writers...DataRemote work
- Merck seeks a Senior Scientist, Statistical Programming in Rahway, NJ to support late-stage... ...and figures across trials and regulatory submissions. The role requires advanced SAS programming... .../ADaM experience, and the ability to lead projects and collaborate with stakeholders...Suggested
- ...Director, Digital Process & Data nalysis (DPDA) (M-track) leads the Operational Reporting... ..., and geographies; set standards and adoption plans for purpose... ...templates, controls, and QA practices to reduce... ...Degree in Computer Science, Statistics, Pharmacy, Nursing, Biological...DataLocal areaRelocationVisa sponsorshipFlexible hoursShift work
- Role Lead clinical schedule management within BARDS, overseeing... ...with SOPs and regulatory standards, manage staff and forecast resources... .... Collaborate closely with statistics, data management, IT, clinical... ...experience with regulatory submissions at leadership level....Data
$117k - $184.2k
...Senior Scientist, Statistical Programming role supporting... ...and regulatory submissions for drugs and vaccines... ...quality deliverables Lead one or more projects and... ...Expertise in SAS including data steps, procedures,... ...Experience with CDISC and ADaM standards Knowledge of...Data$200k - $230k
...Planning Software Engineering Lead, you will provide hands-on technical... ...Estate technology, integrated data and reporting, and AI-enabled... ...the roadmap goals to scale, standardize, automate, integrate, and... ...closely with business analysts and QA to identify technical risks,...DataTemporary workWork at officeRemote work- ...Scientist position in statistical programming for late-stage... ...Sciences division. Leads programming activities... ...global regulatory submissions. Responsibilities... ...execution of departmental standards Requirements BA/... ...SAS expertise including data steps, procedures,...Data
- ...Senior Scientist Statistical Programming role in late-stage... ...deliverables, and leading programming teams across... ...trials and regulatory submissions. Responsibilities... ...SAS expertise including data steps, procedures,... ...systems CDISC and ADaM standards knowledge and...Data
$142.4k - $224.1k
...Scientist role supporting statistical programming for... ...development and regulatory submissions of drugs and vaccines.... ...safety evaluation Lead and coordinate global... ...experience including data steps, procedures, macros... ...with CDISC, ADaM standards, and clinical data management...DataWorldwide$117k - $184.2k
...DescriptionSenior Scientist, Statistical Programming - Rahway,... ...application submissions and post marketing support... ...and global human health.Lead one or more projects.... ...in CDISC and ADaM standards.Experience in designing... ...programming including data steps, procedures, SAS...DataFull timeFor contractorsLocal areaVisa sponsorshipFlexible hours$145.48k - $224.1k
...DUTIES: ~ Support statistical programming activities... ...regulatory application submissions and post-marketing support... ...global and TA standards and following departmental... ...programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; leading large and/or complex statistical...DataFull timeFor contractorsLocal areaRemote workWorldwideRelocationVisa sponsorshipFlexible hoursShift work- ...! is seeking a highly autonomous Lead Software Developer to serve as a... ...impact production.Establish the standards for application responsiveness and... ...experts and medical content (MLR submissions a plus) is advantageous.Hyper-focus on data integrity, UX/UI consistency, and...DataFull timePart timeFlexible hours
$110k - $186k
...to benefit our clients. As a Lead Software Engineer, you will play... ..., workflow automation, and data integration solutions that... ...Ensures adherence to established standards and may consult with senior... ...options for unsolicited agency submissions will be considered.All offers...DataFull timeContract workTemporary workFor contractorsH1bWork at officeLocal areaMonday to Friday- The Senior Lead Engineer job designs information systems that are... ...analysts, engineers, and programmers to design systems and to determine... ..., systems performance standards, and interfaces.Approves and... ...generative AI platforms, or AI-driven data analytics) to solve...DataFull timeWork at office
- Summary: Clinical statistical programmer with hands-on SDTM, ADaM, and TLF production and validation... ...: Develop SDTM datasets from raw EDC data in R (sdtm.oak). Develop and validate... ...Produce TLFs in R (rtables/tern) and submission-ready datasets (xportr) for clinical study...DataInterim role
$200k - $230k
...DescriptionAs a Software Engineering Lead, you will play a crucial role in... ...adherence to security-first coding standards to protect sensitive client data.Review technical designs, code, test... ...including Business Solution Engineers, QA, and business stakeholders, to ensure...DataTemporary workWork at officeRemote work$117k - $184.2k
...This position supports statistical programming... ...regulatory application submissions and post marketing support... ...utilizing global and TA standards and following... ...deliverables for R&D projects (data, analyses, tables,... ...effort of other programmers; experience as a programming...DataFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
...health. This position leads the statistical programming... ...regulatory application submissions and post marketing support... ...global and TA standards and following departmental... ...for R&D projects (data, analyses, tables,... ...effort of other programmers; experience as a programming...DataFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$145.48k - $224.1k
...Principal Scientist role in statistical programming within the Research... ...programming analysis, data transformation, and reporting... ...programming, CDISC SDTM and ADaM standards, and eSubmission package preparation... ...franchise studies, and leading study programming deliverables...Data- ...Reference Number: 23-01045Title: salesforce Lead DeveloperLocation: Iselin, NJ, 08830... ...development Working experience with batch data and real time stream processing on Salesforce... ...demonstrates and follows high standards of integrity in business decision-makingDataWork experience placement
$145.48k - $224.1k
...DescriptionResponsibilities:Provide high quality statistical programming analysis and... ..., retrieve the required data, transform the data into... ...in CDISC SDTM and ADaM standards;Experience in preparing eSubmission... ...PK parameters);Experence leading study programming...DataFull timeFor contractorsSecond jobLocal area$117k - $184.2k
...Senior Scientist role in statistical programming supporting... ...safety evaluation Lead project planning and... ...SAS expertise including data steps, procedures,... ...systems CDISC and ADaM standards experience with... ...compliance, deliverable quality, and regulatory submissions...Data- ...Fin Tech Team. The Financial Systems Lead Developer supports and leads the FIS... ...solving, mentoring, and timely financial data and standard analysis to support management... ...are available as they oversee the Period Submissions and Plan submissions. Whether resolving...Data
- ...EngineerAbout Your RoleAs a Lead AI Transformation Engineer, you... ...:Set and evolve engineering standards (code quality, architecture patterns... ...(SQL, No-SQL) and mainframe data stores where applicable5+... ...does not accept resume submissions from agencies outside of existing...DataFull timeWork at officeVisa sponsorship
$134.55k - $205.56k
...transmission lines from 69kV through 500kV. ~ Knowledge of engineering standards including NESC, IEC, ASCE, ACI, IEEE and ANSI. ~ Experience... ...for our clients. Depending on the role, employees may use data, automation, artificial intelligence, and other digital tools...DataHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours3 days per week$127.89k - $147.9k
Title: Lead Automation EngineerJob Description: The Lead... ...end-to-end design.Lead data analytic efforts for designing... ...selection, design, standards, performance improvement, statistics.Ability to work as part of... ...including working knowledge of Programmable Logic Controllers (PLCs)...DataImmediate start$146.6k - $184.6k
...Senior Manager, Statistical Programming PTC Therapeutics... ...programming standard operating procedures and... ...responsibilities: Leads the statistical programming... ...analyses of clinical data per protocols and... ...Authorisation Applications (MAAs) submissions. Travel...DataContract workTemporary workWork experience placement$134.55k - $205.56k
...through 500kV. ~ Knowledge of engineering standards including NESC, IEC, ASCE, ACI, IEEE and... ...expect people to be willing or able to lead others who use modern tools: You are expected... ...by setting expectations for using data and modern tools such as automation and AI...DataHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours3 days per week
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