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Regulatory Submissions Specialist
Long-term Contract or temp-to-perm position for an Experienced In-house Regulatory Submissions Specialist opportunity with a growing Pharma company! The Role and your Responsibilities • Track, monitor and compile IND/CTA/NDA/MAA and annual report submissions • Perform Submission-Ready formatting and QC • Record Retention and study closeout responsibilities Offering long term stability and a small team work environment where you will have a hand in decisions, strategy and be a valued team member. Skills required: • Experience using Microsoft project, ...
Tags for this job: NDA, MAA, eCTD, ISI toolbox, FDA submission, NDA publishing
View Regulatory Submissions Specialist Job - Branford, CT 06405
Biostatistician
12 months extendable contract Responsibilities will include, but are not limited to, the following: Actively provide statistical support to the Medical Affairs Department • Provide statistical support for publications, presentations, posters at medical meetings and any other requests not covered in the clinical study report. This includes data mining, meta-analysis, and support for data-driven analyses. • Interact with authors, referees and in-house reviewers in the preparation of publications, presentation and posters. • Provide statistical reviews of proposed ...
Tags for this job: Biostatistics, Biostatistician, PhD, SAS
View Biostatistician Job - Summit, NJ 07902
Biostatistical Programmer
Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), electronic submissions and other internal and external requests (e.g., publications). Accessing and converting data to SAS from Database management system ...
Tags for this job: oncology, statistics, programming, SAS, SQL, SAS/BASE, SAS/STAT, PhReg, GLM, Mixed, Lifetest, T-Test, efficacy, TLG
View Biostatistical Programmer Job - Woodcliff Lake, NJ 07677
Sr. Clinical Data Analyst
Manage the creation, execution and maintenance of Data Management Plans in support of clinical study deliverables. Lead the design, creation and lifecycle management of data collection, validation and reporting specifications and usage guidelines. Support the training and development of certain CDM study personnel (e.g. Clinical Data Analyst I & II’s) through formal training and guided mentorship. Support the preparation of project budgets and financial reporting. Assist in the development of study resourcing plans and direct the activities of certain CDM study p...
Tags for this job: CDISC, Biostatistician, Data Manager, CDM, Data Management, Clinical Data Manager, Clinical Data, Oracle Clinical, Clinical Research, Pharmaceuticals, Biotech, Research, Data Coordinator, Clinical Programmer, Research, Oracle Clinical, CRFs, EDC, Electronic Data Capture
View Sr. Clinical Data Analyst Job - Westlake Village, CA, CA 91361
Regulatory Documents Specialist
Responsible for independently formatting and publishing electronic documents for Regulatory submissions. Integrates and applies strong knowledge of US electronic regulatory submission requirements in support of ongoing drug development programs. Requires some guidance from direct manager. Essential Functions of the Job (Major Duties and Responsibilities): -Independently formats and publishes electronic Regulatory submission documents and ensures quality, accuracy, and submission readiness per Regulatory agency guidance and specifications. Will QC others work. -Devel...
Tags for this job: regulatory documents, publishing, formatting, IND, BLA, submissions, title 21CFR
View Regulatory Documents Specialist Job - New York, NY 10591