Writing SAS programs from instructions provided by Biostatisticians and Statistical Programmers to create CDISC data sets, tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications Utilize SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH Create all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE Work with all types of safety data and ...

Trackwise Administrator Location: suburban Philadelphia area Support TrackWise •Perform business requirements gathering, requirements analysis, business system design, installation, configuration, user testing and validation support of TrackWise based applications •Lead and drive value-added TrackWise expansion into applicable areas and departments •Perform report customization using Crystal Reports for TrackWise and other reporting tools •Troubleshoot problems with existing configurations, master data selection lists, interfaces and reports ...

Remote Contract (W-2 or C2C)- 12 months Renewable- Sr. Biostatistician 1 year potentially renewable contract POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data ...

Remote Contract (W-2 or C2C)- 12 months Renewable- Sr. Biostatistician 1 year potentially renewable contract POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data ...

Remote Contract (W-2 or C2C)- 12 months Renewable- Sr. Biostatistician 1 year potentially renewable contract POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data ...

DOCS Global is the premier resource provider in the biopharmaceutical and medical device industries. We currently have an exciting opportunity available in Toronto, Canada. The Senior Site Manager serves as primary contact point between the sponsor and the investigational site. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through ...

Acts as an in-house Clinical Research Associate providing support to clinical functions and site customers through site start up, enrollment, follow up and closure phases of clinical trial activities. Key Responsibilities: Site Start-Up: works across several studies to ensure all required documentation is in place in order to authorize sites for study enrollment. Partner with other team members to support patient enrollment. Communications: ensures clear written communication to clinical sites and project team members through monitoring repor...

Oversee, lead, and manage cross-functional team resources and external service providers (including clinical operations, medical monitoring, safety, data management, auditors, and consultants) to conduct trials on time, on budget, in compliance, and of highest quality. Coordination/execution of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles). Work collaboratively with cross functional inte...

Clinical MEDICAL GENETICIST JOB OPENING IN WESTCHESTER COUNTY NY (30 minutes North of NYC) An exciting opportunity to join an established Comprehensive Medical Genetics practice serving in NYS. We are seeking a full-time tenure track Biochemical/Clinical Geneticist to join our Inherited Metabolic Disease Center and Clinical Genetics Practice. We are a Newborn Screening Referral Center and also have an active Lysosomal Storage Disease Center managing a large cohort of patients. Our physicians are part of a network which have academic appointme...

Job Description This role manages the outsourcing of clinical development projects to external service providers on behalf of Global Clinical Operations, allowing on-time, on budget and on quality delivery of clinical data to support the potential registration of new products. The role will require the use of advanced analytical skills to review complex clinical study assumptions and budget data and will require business knowledge of the clinical development process and close collaboration with internal and external key stakeholders. Responsibil...

This is a new role for the pharmaceutical company where they are looking for a Manager who can help them to prepare for Inspection Readiness. They are filing several new products with the FDA this year and want to have someone who has had experience preparing for FDA, MHRA and other regulatory authority audits associated with filing new products. They want a Project Manager to help them to organize this but this person has to have had Quality Management experience. Summary/Scope: Lead program teams through the activities of preparing for wor...

We are a smaller medical device company with products marketed globally. Job Purpose Implement regulatory submission strategies and manage regulatory requests for a wide array of regulatory documents, statements and dossiers in coordination with Regulatory HQ. Provide consultation, guidance and recommendations to relevant Company Functions relative to matters of US Regulation and foster constructive interactions with Regulatory Agencies and Certification Bodies. Responsibilities • Implement regulatory compliance strategies in coordinati...

Opportunity to work in the clinical trial agreements and contracts area for a leading global pharmaceutical company. JOB DESCRIPTION: Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts and grants related to clinical trials. Assists in and/or directs the development of scope of work and analysis of terms and conditions. Provides specialized support to trial managers and clinical group in the pricing, planning, execution and control of grant...

Opportunity to work in the clinical trial agreements and contracts area for a leading global pharmaceutical company. JOB DESCRIPTION: Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts and grants related to clinical trials. Assists in and/or directs the development of scope of work and analysis of terms and conditions. Provides specialized support to trial managers and clinical group in the pricing, planning, execution and control of grant...

Our client, a growing Oncology Biotech company in the RTP area, is currently hiring a Director, Clinical Scientist and expanding their team!! The Director Clinical Scientist is a key member of the clinical development team for the planning, conduct, analysis, and reporting of clinical studies. This position works independently across functional teams to ensure the timely execution of the clinical development plan. Requires minimal supervision in the development of protocols, analysis of clinical trial data, literature searches, and summary of key ...

Our client, a growing global pharmaceutical company, is currently seeking qualified candidates for full-time positions in their Medical Affairs department for their South Central region. The successful candidates will have a Doctorate degree (MD, OD, PharmD, PhD,) with 2 - 8 years of experience required as an MSL in the pharmaceutical industry. Experience in Ophthalmology is required. The Medical Science Liaison (MSL) will be responsible for engaging and developing relationships with national and regional Medical Experts (MEs) within their geogr...

Our client, a growing global pharmaceutical company, is currently seeking qualified candidates for full-time positions in their Medical Affairs department located in the South Central region. The successful candidates will have a Doctorate degree (MD, OD, PharmD, PhD,) with 2 - 8 years of experience required as an MSL in the pharmaceutical industry. Experience in Ophthalmology is required. The Medical Science Liaison (MSL) will be responsible for engaging and developing relationships with national and regional Medical Experts (MEs) within their ...

Job Title: Principal Engineer, Delivery Systems Our client, a growing global pharmaceutical company, is seeking qualified candidates for a full-time Principal Engineer, Delivery Systems Development position in R&D, Implant Manufacturing division located in Durham, NC. This position will be responsible for driving the development and manufacture of implant delivery devices used for their extended-release, sterile, ophthalmic products from early pre-clinical development through phase 3 clinical studies. Essential Duties & Responsibilities: T...

Writing SAS programs from instructions provided by Biostatisticians and Statistical Programmers to create CDISC data sets, tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications Utilize SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH Create all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE Work with all types of safety data and ...

- 12 month long term contract - Remote The senior statistical programmer position will be responsible for manipulating large databases and generating reports using SAS to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS programming skills and the ability to implement complex data step logic. Candidates must be comfortable with creating complex analysis data sets derived from various data sources with a careful eye for outliers and errors. Prior experience with large databases and observational research...

DOCS Global is hiring! We are THE premier resource provider in the biopharmaceutical and medical device industry. Join our team as a Grants Analyst and realize your career growth opportunities. Specs: • Manage relationships with vendors to ensure all invoices are received and paid in accordance with the terms of corresponding Contracts or Statements of Work • Manage responses to internal and external stakeholder inquiries regarding invoicing, contracts, reconciliations, aging reports, and other special requests. • Ensure the optimum financial...

- Onsite preference San Diego or remote - 1 year potentially renewable contract POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data management, clinical operation...

The purpose of the Director of Analytical Development is to provide the planning, development, qualification and execution of analytical assays to support internal Research & Development, Process Development and recombinant vector manufacturing. The successful candidate will have a Master’s or PhD degree in Bioanalytical Chemistry, Chemistry, Biology, Biochemistry, Virology or related field and have a working knowledge of qPCR, ELISA, SDS-PAGE/Western blot, HPLC, RP-HPLC, HPLC-SEC and cell based potency assays etc. This individual will lead an analy...

- 9 month potentially renewable contract - Onsite NJ CORE JOB FUNCTIONS: • Responsibilities will include analysis of clinical trial data with emphasis on translational data in addition to analysis of clinical, quality of life and of real world data. • Work under the direction of Medical Affairs Statistics Disease Lead. • Actively provide statistical support in the Medical Affairs Department, with emphasis on support of translational research. • Actively provide statistical support to the Medical Affairs Department. • This position coul...

Senior Director, Medical Affairs The Head/Sr. Director of Medical Affairs provides overall strategic and operational medical and scientific leadership for all medical affairs activities. It includes building and leading a best-in-class Medical Affairs organization and supporting the development and, ultimately, the commercialization of all pipeline products. The initial focus will be in the U.S. and Europe supporting development with a global scope of responsibility for the overall portfolio with a focus on increasing awareness externally for ...

Reporting to the Vice President of Clinical Development, the Clinical Development Lead will be responsible for providing innovative scientific knowledge, skill, and technical expertise for assigned clinical programs, and projects. This position is responsible for the development of gene therapy products to treat neovascular (wet) age-related macular degeneration. We utilizes a cross-functional product development team approach to effectively support the initiation, development and registration of candidate drugs. The Senior Director Clinical Research ...

- 1 year renewable contract - Onsite NJ Develop, program, test and maintain clinical trial databases and data entry screens using Rave in accordance with standards Lead collaborative cross-functional team study build meetings for in-house and outsourced studies Review edit checks for in-house and outsourced studies Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and standards Participate in and lead team meetings when appropriate Act as primary CRO contact, when ne...

5+ years' experience as a CRO SAS Programmer CDISC experience (SDTM, ADaM, Define.xml) Experience leading multiple studies across multiple TAs. Experience with Sponsor interaction and bid process activities Experience leading a project team Conduct QC/Validation of SAS code Expertise in SAS language options including Macro language, BASE SAS, SAS/STAT and SAS/GRAPH BS/MS Math, Statistics, Computer Science, or related field

This PM role will focus on Specialty R&D development projects in North Carolina and PM support for Specialty R&D development projects in India. Role responsibilities include components of: resource management, financial management, quality management, risk management, control management and business continuity management. DUTIES & ESSENTIAL JOB FUNCTIONS Help define the project charter, roles, tasks, milestones, budgets and measures of success to support the business case. Develop project estimates and plans to manage end-to-end project execu...

Develop and maintain datasets as per the CDISC (SDTM and ADaM) standards; Extract data from various databases; Develop and maintain programs to analyze the data and produce reports consisting of Tables, Listings and Graphs that are generated from the available databases; Apply Programming Development Life Cycle (PDLC) principles; Develop programs using SAS(Statistical Analysis Software) and SQL; Perform Programming using SAS software analyzing the clinical trial data to produce the outputs for the clinical trial report; Prepare specifications an...

The R2 Medical Writer will prepare trial disclosure documents in compliance with trial transparency laws and requirements and client policies. • Clinical trial registration and results posting on www.ClinicalTrials.gov. • Coordinating quality assurance reviews of documents and maintain audit trails of changes. • Prepares scientifically valid draft and final narratives for posting to www.ClinicalTrials.gov, inclusive of the scientific interpretation of data, and the writing of clinical, pharmacokinetic and pharmacodynamic results for studies o...

The Sr. Director/Director, Clinical Operations is a member of the Clinical Operations Department. The Clinical Operations department is responsible for the management (planning, implementation, maintenance and close out) of the Clinical trials with a focus on the investigators (+ staff), regulations, compliance, timelines, data collection and review, and safety. There are approximately 10 employees in the department with some of the activities outsourced to Clinical Research Organizations. The Sr. Director/Director, Clinical Operations will lea...

The selected candidate will serve as the technical leader on all data management aspects for project(s) including start-up,maintenance, and completion activities and develop [Global]Data Management Plans and Quality Management (QM) plans that will deliver accurate, timely, consistent, and quality clinical data. Additional responsibilities include: • Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and + Coordinate and participate in the development ...

REPORTING RELATIONSHIPS Direct reports: up to 5 DUTIES & ESSENTIAL JOB FUNCTIONS Develop Site Quality Road Map for the initiation of Manufacturing GMP Quality Systems Establishing and maintaining Site SOPs in collaboration with Mfg. staff Create and maintain Site Master Validation Plan Review of Batch Records and approve product disposition Review of analytical, stability test methods, protocols & reports Release of raw materials, components, in-process materials and finished products Review and approve investigation reports as appl...

• Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions. • Creation/distribution of regulatory binders & the wet-ink signed documents binder • Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Respond to problems and assists in implementing correct...

Our client, a growing Oncology pharmaceutical company located in the RTP area, is currently hiring a new position for their growing team! Primary Job Responsibilities: • Lead efforts for coordinating CMC content for original INDs, IND amendments, IMPDs, for inclusion in Clinical Trial Applications and NDAs • Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including Investigator Brochures, DSURs and background documents for Regulatory Authority meetings • Provides strategic CMC regulatory interpretation an...

Overall responsibility for the management of US Regulatory Affairs matters and maintenance of NDAs relating to the approved pharmaceutical products portfolio, in support of the business goals. This includes: • Review and approval of promotional materials in accordance with labelling including oversight of filing of 2253s • Review and approval of packaging materials in accordance with labelling, and approval of artwork through partner electronic portal • Maintenance of NDAs including coordinating compilation and submission of ad hoc reports, aggreg...

Description Technical review of raw data for the QC group Technical review of method transfer/verification protocols Technical writing of specification documents, standard test procedures, general test procedures, SOPs, qualification protocols Review, manage, and monitor stability trend tables Support investigations that arise in the QC testing of raw materials/finished products as needed Work with all parties as applicable, technical services, material management, manufacturing, packaging, and the laboratory to identify the breadth and scop...

The Clinical Trial Manager is a critical component in the execution of a clinical trial. Engagement of highly motivated clinical investigators will enable company to maximize efficient and timely delivery of clinical trials. This position is responsible for contributing to an industry leading site engagement team. The Clinical Trial Manager is responsible for providing operational expertise to sites through ownership/management of Site Engagement Strategy. The scope of this role includes the following: • Define and implement strategies for enga...

The Clinical Trial Manager is a critical component in the execution of a clinical trial. Engagement of highly motivated clinical investigators will enable company to maximize efficient and timely delivery of clinical trials. This position is responsible for contributing to an industry leading site engagement team. The Clinical Trial Manager is responsible for providing operational expertise to sites through ownership/management of Site Engagement Strategy. The scope of this role includes the following: • Define and implement strategies for enga...

Senior Manager, Statistical Programming, onsite, Marlborough, MA - Provide statistical programming support to clinical trials for regulatory submissions and various publications, posters, … etc. - Support the Biostatistics function in statistical analysis including generating analysis data sets, patient listings, tables and figures for clinical trials. - Develop and maintain the infrastructure for project files of SAS datasets and SAS programs. Essential Functions: 1. Provide statistical programming support to clinic...

Salary up to 140K, Willing to pay for relocation, Offers free paid time off the week in between Christmas and the new year, open to Visa sponsorship, However US citizenship preferred given the delay in start-time to sponsor individuals. This position is based in either site Tarrytown, NY, or Basking Ridge, NJ offices. Note: The other 'CNS' biostatistician position must be based in Basking Ridge 'only'. Summary: The Biostatistics and Data Management group is looking for a Biostatistician to support Clinical Development and Exploratory Sciences. Th...

- 6 month renewable contract- Pharmaceutical Client - Remote - Required to work pacific hours Required Previous Experience Includes: *Oncology experience required Creation of datasets and Tables or QC of these outputs Both safety and efficacy (AE tables all types, Lab shift tables, Exposure tables, PFS, OS, DOR, ORR, TTE) Experience in generating figures (Kaplan Meier, forest plot, waterfall) SDTM, ADAM, SAS 9.4, BASE, ODS, SAS/STAT, SAS/GRAPH, SAS Macro

The Clinical Trial Manager is a critical component in the execution of a clinical trial. Engagement of highly motivated clinical investigators will enable company to maximize efficient and timely delivery of clinical trials. This position is responsible for contributing to an industry leading site engagement team. The Clinical Trial Manager is responsible for providing operational expertise to sites through ownership/management of Site Engagement Strategy. The scope of this role includes the following: • Define and implement strategies for enga...

The Associate Director will support and expand the clinical microarray program. Responsibilities: Serves as an expert for review, interpretation and sign-out of microarray results. Reviews, interprets and reports other assays used for detection of copy number variants such as MLPA and qPCR. Provides skilled management and interpretation of complex copy number variant cases Assists with improvement to analysis and reporting workflows Assist with training of analysts when new practices are established Manages laborat...

Location MA Job type Full-time Summary of Responsibilities Work to create/maintain library of company metadata standards, including CRFs, Datasets, Variables, Value List, Controlled Terminology, Computation Method definitions in a single, easy to navigate repository that describes the data standards targets. Work to keep abreast of and incorporate new and updated data standards issued by CDISC and other Standards Development Organizations (SDO) which impact data processing activities within Data Science and other R&D functions that proce...

The senior statistical programmer position will be responsible for manipulating large databases and generating reports using SAS to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS programming skills and the ability to implement complex data step logic. Candidates must be comfortable with creating complex analysis data sets derived from various data sources with a careful eye for outliers and errors. Prior experience with large databases and observational research methods such as epidemiology and statist...

RESPONSIBILITIES: • Molecular Genetics/Pathology • Ability to interpret the clinical significance of genomic variants • Ability to synthesize summaries on complex genomic mutation profiles • Ability to make complex scientific judgments • Provides consultations to care providers. • Write and sign molecular genetic reports summarizing analyses, results, and conclusions. • Works with laboratory staff to address clinical issues promptly. • Assist with the planning and implementation of the quality control and quality assurance programs. • Assist ...

**Dual boarded is preferred. We would like someone that can do a 75/25 split MDX/cytogenetics. A really good candidate for MDX only would also be considered. The Associate Director of Molecular Diagnostics assists with the strategic maintenance/development of the Molecular Diagnostic laboratory.** JOB RESPONSIBILITIES Writing and reporting: Cytogenetics / FISH /microarray cases. Assists in strategic development of the laboratory services. Assists in the development and implementation of polices and procedures that guide and suppo...

The Senior Software Development Engineer will be a contributor to the development team, developing software for the Integrated Respiratory Information System, Business Intelligence, and other applications. This position will work as a software development engineer and and help define product specifications, and design, implementation and testing required to effectively allow the applications to consume respiratory medical device and related 3rd party data stored in the SQL data base. As the person in this role develops more experience he/she will pro...