Remote, 12-month contract with potential to renew The Real-World Evidence (RWE) function is part of the Clinical Data Sciences (CDS) group within the Clinical Development organization and aims to unlock the power of Real-World Data (RWD) to help transform innovations to life-changing medicines for patients. The Study Coordinator / Medical Writer II is responsible for the facilitation of real-world research study activities in support of the current pipeline and expanding product portfolio. Success in this role requires direct experience in coordinating RW...

We are seeking a highly-motivated Research Scientist, Applied Statistical Genetics to join our team within the Genomics and Data Science (GDS) group. This position will provide support and leadership to our company vision to perform large-scale target discovery using African genomic datasets. The GDS team is responsible for implementing workflows to analyze sequence and array datasets and for performing target discovery analyses across rare and common diseases. The ideal candidate will have strong analytical and programming skills with experience in the a...

Remote, 12 month contract Description: 12 month renewable remote contract Responsibilities: • Advises on database selection, patient population selection and statistical analysis plans • Executes on statistical analysis plans • Perform RWD analytics QC including to assess if research project programs are aligned with statistical analysis plans • Tracks and archives RWE-A projects in accordance with department standards • Remains current on medical coding systems and relevant large healthcare databases; develops and maintains statistical programming skills...

Remote, 12-month contract, potentially renewable Position Summary: The Senior Statistical Programmer will work closely with the Director of Statistical Programming and other members of the Biometrics team to provide programming support across specific programs. The ideal candidate will provide hands-on programming and validation support to project teams Essential Responsibilities: Programming and QC of SDTM and ADaM data sets Validating data sets and TFLs produced by vendors Running compliance checks on SDTM and ADaM data sets Re-running another programme...

Remote, long term opportunity, w2 or corp to corp accepted At least 8 years of hands-on experience in Stat Programming with no employment gaps. At least 4 years hands-on experience working on SDTM and ADaM data sets Hands-on experience in oncology and submissions (preparing metadata for a study and/or working on an ISS or ISE) Strong communication skills, both written and verbal Demonstrated attention to detail and focus on quality, supported by examples Demonstrated proactivity, supported by examples Demonstrated analytical skills, for example by creatin...

The majority of critical meetings are before 10 am Pacific (some are as late as 2pm Pacific) - candidates should be available for these but the rest of the schedule is flexible Target 10-12 years of experience ideally with some recent experience direct with a sponsor ***Would like to have study design experience for IBD/GI (ulcerative colitis, Crohn’s disease, EOE) Must haves: Good expertise with SDTM/ADaM Recent experience with ISS/ISE or NDA submissions One area that is critical is communication skills. English is not the first language for many industr...

Our client, a growing smaller company and GREAT team, are looking for a remote, full-time Clinical Project Manager to join them! The Project Manager oversees and coordinates the operational aspects of ongoing clinical projects to ensure that the clients’ goals of time, cost, and quality are met. Also serves as the primary contact with the client to ensure appropriate communications, project budget management, and meeting of timelines. The Project Manager is responsible for the successful conduct of all client projects, including client satisfaction and op...

Our client, a growing smaller company and GREAT team, are looking for a remote, full-time Clinical Project Manager to join them! The Project Manager oversees and coordinates the operational aspects of ongoing clinical projects to ensure that the clients’ goals of time, cost, and quality are met. Also serves as the primary contact with the client to ensure appropriate communications, project budget management, and meeting of timelines. The Project Manager is responsible for the successful conduct of all client projects, including client satisfaction and op...

Remote Lead SAS programmer, contract, possible to convert to FTE, CDISC, SDTM, ADaM, ISS, ISE...

Our client, a mid-sized privately owned clinical research organization, is looking for a full-time,, homebased Clinical Trial Associate to join their team! • Supports project teams in the planning, execution, control, reporting and closure of clinical projects according to the company's SOPs and established project-specific plans. • Establishes, maintains, QCs and transfers eTMF/TMF/project files per SOPs and project-specific plans. • Establishes, provides access to, maintains and updates required information for assigned projects in the CTMS and other de...

Remote, 12-month contract with potential to renew Position Summary The Senior Statistical Programmer plays a lead role in designing, developing, testing, maintaining, validating, and documenting SAS programs to evaluate clinical data and meet the project requirements for SAS statistical programming efforts for clinical and non-clinical projects and studies. Provides advanced technical expertise to the development of programming standards and procedures. Responsibilities: • Provides advanced technical statistical programming leadership to the Statistical P...

See brief job description below: (this is a template job description so for each location it differs slightly but not by much) LEAD CYTOGENETICS/FISH TECHNOLOGIST Full time Day Shift PRIMARY RESPONSIBILITY: Demonstrated deep knowledge, understanding and high level skills in the field of conventional cytogenetics and FISH. Validates, runs and analyzes conventional cytogenetics and FISH analyses, summarizes the tests results utilizing ISCN nomenclature, maintains clinical and internal documentation files Works in close collaboration with the Cytogenomics Di...

Senior Statistician, remote, create and review protcols, SAPs, advanced statistical analysis methods, SAS, pharmaceutical or Biotech experience Remote, 12-month contract with potential to extend IBD/BI (ulcerative colitis, Crohn’s disease, EOE) is TA The Study Lead Statistician is responsible for leading, providing technical leadership, and biostatistical support to the Clinical Development research program through design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results; ...

6-month renewable remote contract Key Responsibilities: Support targeted research of epidemiology of specific disease areas, including incidence/prevalence, BOI, and NH of disease for business development and early development indications Contribute to registry strategy for early development and early clinical indications to support BOI or NH of disease needed for regulators, payers, and clinicians Lead and execute evaluation of available registries and other data sources related to BOI or NH Determine potential use of RWE historical control within clinic...

6-month renewable remote contract Key Responsibilities: • Support targeted research of epidemiology of specific disease areas, including incidence/prevalence, BOI, and NH of disease for business development and early development indications • Contribute to registry strategy for early development and early clinical indications to support BOI or NH of disease needed for regulators, payers, and clinicians • Lead and execute evaluation of available registries and other data sources related to BOI or NH • Determine potential use of RWE historical control withi...

Contributes to development of global regulatory documentation strategy and execution of tactics. Conceptualizes and develops medical communications for message-driven, concise reviewer-friendly clinical documents in order to support regulatory agency review. Coordinates medical writing/regulatory submission progress against global regulatory strategic communication plans. Writes or co-ordinates writing and reviews of clinical trial reports, narratives, clinical trial protocols, local working instructions, submission documents (ISS, ISE, CO, RMP), investig...

The Senior Programmer is responsible for managing the inflow of a variety of healthcare claims and EMR databases, checking quality, developing specifications, transforming data to a common data model, and publishing data for use by statistical programmers, analysts and data scientists across the company. The qualified candidate must also be able to provide reports, presentations and detailed explanations to epidemiologists, analysts and programmers and work in collaboration with both internal and external partners. Prior experience with large databases an...

This position will work closely with the Director of Statistical Programming and other members of the Biometrics team to provide programming support across specific programs. The ideal candidate will provide hands-on programming and validation support to project teams Essential Responsibilities: • Program analysis datasets, statistical tables, figures, and listings. • Generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation. • Provide statistical programming and validation support for clinical study reports and...

12 month renewable contract - Remote - The minimum education requirement is a Master’s degree in Statistics, Biostatistics or other subject with high statistical content. - Min. 2 years of pharma/biotech experience with a PhD or 4 years with a master's degree - Experience in hematology, oncology or immunology therapeutic areas (at least one of those areas) - FDA or European regulatory experience and in-depth knowledge of regulatory regulations and guidelines. - Experience working on study protocol, study design, statistical analysis plans, and ad-hoc anal...

Tumor CytoGenomics Assistant/Associate Director: Our Client is seeking a Clinical Cancer CytoGenomic expert for the position of Assistant/Associate Director. The Tumor Cytogenomics Assistant/Associate Director will share responsibilities for this essential laboratory dedicated to the detection of acquired chromosomal abnormalities associated with hematological malignancies and solid tumors. The outstanding faculty candidate must possess a Ph.D. and/or M.D. and preferably is Board-certified by the American Board of Medical Genetics in Clinical Cytogenetics...

Terrific opportunity to join a growing team! JOB SUMMARY Provide comprehensive data management expertise and efficient, quality data management services that meet sponsor needs. The Lead Clinical Data Manager is responsible for the data management for studies and oversight of the Clinical Data Managers. REQUIRED EDUCATION, KNOWLEDGE, SKILLS AND ABILITIES • The position requires at least a Bachelor’s Degree in clinical, biological, or mathematical sciences with minimum of 8+ years of experience in clinical data management in clinical trials, at least 5 yea...

Great full time opportunity to join a company with a positive culture and reasonable travel! (Eight days on site per month) Qualified CRA candidates will ideally have 3-5 years of experience in field monitoring for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs), applicable local and international regulations and Standard Operating Procedures (SOPs). CRAs are responsible for the quality of data submitted from study sites. In addition, CRAs must ass...

Great full time opportunity to join a company with a positive culture and reasonable travel! (Eight days on site per month) Qualified CRA candidates will ideally have 3-5 years of experience in field monitoring for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs), applicable local and international regulations and Standard Operating Procedures (SOPs). CRAs are responsible for the quality of data submitted from study sites. In addition, CRAs must ass...

Our client, a growing smaller company and GREAT team, are looking for a remote, full-time Clinical Project Manager to join them! The Project Manager oversees and coordinates the operational aspects of ongoing clinical projects to ensure that the clients’ goals of time, cost, and quality are met. Also serves as the primary contact with the client to ensure appropriate communications, project budget management, and meeting of timelines. The Project Manager is responsible for the successful conduct of all client projects, including client satisfaction and op...

Small clinical stage biopharmaceutical company, Kidney TA, remote, 12 month contract, small team, need a leader and experienced working independently and together in small infrastucture. - 12 month renewable remote contract The Senior Statistical Programmer will be responsible for the planning, implementation, and compliance of clinical trial statistical programming activities across multiple studies to produce high quality and timely deliverables for global submissions. In addition to overseeing internal statistical programming activities, the role will ...

KEY RESPONSIBILITIES include (not an exhaustive list of duties): Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget Monitor project resourcing, project budgets, and identify changes in scope Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards Maintain all supporti...

Job Description Responsibilities: At least 8 years of hands-on experience in Stat Programming. Note, positions mostly providing oversight of outsourced projects are not considered hands-on At least 4 years hands-on experience working on SDTM and ADaM data sets Hands-on experience in oncology and submissions (meaning, preparing metadata for a study and/or working on an ISS or ISE) Strong communication skills, both written and verbal Demonstrated attention to detail and focus on quality, supported by examples Demonstrated proactivity, supported by examples ...

This position will work closely with the Director of Statistical Programming and other members of the Biometrics team to provide programming support across specific programs. The ideal candidate will provide hands-on programming and validation support to project teams Essential Responsibilities: • Program analysis datasets, statistical tables, figures, and listings. • Generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation. • Provide statistical programming and validation support for clinical study reports and...

Clinical Laboratory Technologist Chemistry/Virology Position Summary We have an exciting opportunity to join our team as a Clinical Lab Technologist in Chemistry Department or Virology Department. Currently we are seeking personnel for full time night shiftandweekends. In this role, the successful candidateresponsible for performing complex clinical laboratory tests on specimens for diagnostic purposes under minimal supervision. Job Responsibilities Performs laboratory tests and procedures, which require technical skill and an exercise of independent judg...

- Client has an urgent need for a statistical programmer with extensive validation experience. Will be validating SDTMs and ADaMs produced by CRO via independent programming - Must have extensive risk-based validation experience - Early development experience preferred - Review SDTM and ADaM specifications in details. Must be able to understand the protocol and SAP when reviewing the programming specifications. - Familiarity with clinical trial design and analysis activities. Strong knowledge of CDISC SDTM and ADaM data models - Strong SAS programming ski...

12 month remote renewable contract Top 3 Must Have Skill Sets: * SAS experience * Pharma industry experience * Statistical Analysis experience * Experience with claims databases (big plus) Work under the direction of Medical Affairs Statistics Disease Lead. • 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 meta-analysis, multivariate analysis, use of graphical R an...

- Client has an urgent need for a statistical programmer with extensive validation experience. Will be validating SDTMs and ADaMs produced by CRO via independent programming - Must have extensive risk-based validation experience - Early development experience preferred - Review SDTM and ADaM specifications in details. Must be able to understand the protocol and SAP when reviewing the programming specifications. - Familiarity with clinical trial design and analysis activities. Strong knowledge of CDISC SDTM and ADaM data models - Strong SAS programming ski...

- Client has an urgent need for a statistical programmer with extensive validation experience. Will be validating SDTMs and ADaMs produced by CRO via independent programming - Must have extensive risk-based validation experience - Early development experience preferred - Review SDTM and ADaM specifications in details. Must be able to understand the protocol and SAP when reviewing the programming specifications. - Familiarity with clinical trial design and analysis activities. Strong knowledge of CDISC SDTM and ADaM data models - Strong SAS programming ski...

Responsibilities Working in the Molecular Pathology department with a strong emphasis on Women's Health testing Carrying out HPV and STD testing Working with platforms such as SDA, real-time PCR, capillary electrophoresis, pyrosequencing, microarray technology and NGS. Assists supervisor with SOP's and regulatory requirements. Qualifications Bachelors of Science degree Must obtain a current Florida MT License Molecular Biology (additional licensure Microbiology, optional) MT ASCP or MB (ASCP) 3-5 years molecular pathology experience a must Candidate must ...

The Clinical Trials Assistant (CTA) will support the clinical project team in the following areas: study start-up and site regulatory document collection; accurately update and maintain clinical systems within project timelines; prepare, handle, distribute, file, and archive clinical documentation and reports; review of study files periodically for accuracy and completeness; prepare, handle and distribution of Clinical Trial Supplies and maintenance of tracking information; track and manage Case Report Forms (CRFs), queries and clinical data flow. May act...

100% Remote position- FTE. Must have excellent SAS and SQL experience, as well as extensive experience working with large, real world healthcare data. The senior 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...

100% Remote position- FTE. Must have excellent SAS and SQL experience, as well as extensive experience working with large, real world healthcare data. The senior 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...

12 month renewable contract - Remote - The minimum education requirement is a Master’s degree in Statistics, Biostatistics or other subject with high statistical content. - Min. 2 years of pharma/biotech experience with a PhD or 4 years with a master's degree - Experience in hematology, oncology or immunology therapeutic areas (at least one of those areas) - FDA or European regulatory experience and in-depth knowledge of regulatory regulations and guidelines. - Experience working on study protocol, study design, statistical analysis plans, and ad-hoc anal...

Flow Cytometry JOB openings in FL. The Flow Cytometry Technologist is responsible for daily specimen processing in the clinical flow cytometry laboratory. Communicates with staff physicians and other staff employees regarding patient specimens. Works with management personnel to ensure efficient and technically correct systems and procedures in the clinical cytometry laboratory that includes QA/QC of reagents, instrumentation, proficiency testing, etc. Qualifications Bachelor's Degree in Clinical Lab, Chemistry, Biology or related field and completed an a...

This position will work closely with the Director of Statistical Programming and other members of the Biometrics team to provide programming support across specific programs. The ideal candidate will provide hands-on programming and validation support to project teams Essential Responsibilities: • Program analysis datasets, statistical tables, figures, and listings. • Generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation. • Provide statistical programming and validation support for clinical study reports and...

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 operations, biostatistics, and programming and will oversee the work of statistics and programming e...

The Senior Programmer is responsible for managing the inflow of a variety of healthcare claims and EMR databases, checking quality, developing specifications, transforming data to a common data model, and publishing data for use by statistical programmers, analysts and data scientists across the company. The qualified candidate must also be able to provide reports, presentations and detailed explanations to epidemiologists, analysts and programmers and work in collaboration with both internal and external partners. Prior experience with large databases an...

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 operations, biostatistics, and programming and will oversee the work of statistics and programming e...

- 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...

Onsite - San Diego 12 month renewable contract Responsibilities will include, but are not limited to, the following: • Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. • Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results. • Perform programming validation to ensure the quality of analysis datasets and programming outputs. • Ensure consistenc...

Long-term remote FSP - West-coast based (pacific or mountain time) * Min. 12 (ideally 15) years of statistical programming experience. * Prior experience leading/managing projects/people is critical * Must have extensive experience with Kaplan-Meierplots * Must have great communication skills, ability to work independently Responsibilities will include, but are not limited to, the following: • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. • Perform ad hoc flexible and rapid programming arising from questions generat...

H1B transfer, stock, bonus, and relo. - Onsite San Diego - Min. 8 years of statistical programming experience in Pharma/Biotech _______________________________________________________________________ Function/Scope: As a Clinical Statistical Programming, you play a key role in developing, implementing and evaluating statistical programming standards and processes. You will be responsible for the production of selected project related Tables, Listings, and Figures (TLF), patient profiles, and integrated summaries of efficacy and safety data as required. Pr...

12 month renewable (potential contract to hire after 12 months)- Onsite San Diego with a very promising pharma client Description Responsible for collaborating with statisticians and data managers on the statistical programming strategy for multiple clinical studies. Serves as primary in-house programmer on multiple studies. Participates in the development of programming strategy for clinical studies, case report forms, database design, data management plans, programming specifications and statistical analysis plans. Responsible for production and quality...

Our client, a growing smaller company and GREAT team, are looking for a remote, full-time Clinical Project Manager to join them! The Project Manager oversees and coordinates the operational aspects of ongoing clinical projects to ensure that the clients’ goals of time, cost, and quality are met. Also serves as the primary contact with the client to ensure appropriate communications, project budget management, and meeting of timelines. The Project Manager is responsible for the successful conduct of all client projects, including client satisfaction and op...

(Below job description is just a template. Not the actually job description from this particular lab in Seattle.) JOB SUMMARY: Responsible for day to day processing and analysis of Cytogenetic, FISH samples JOB RESPONSIBILITIES/ ESSENTIAL FUNCTIONS: Performs all duties of a Cytogenetic Technologist. Must perform within the productivity expectations as set forth by current departmental guidelines. Assists in documentation and maintaining effective department QA programs and monitors. Assists in the training of new employees and trainees in accordance with ...