Our client company has taken steps to create a pathway for more growth. The details have been approved and the company is moving froward aggressively with new business development. The company leadership is optimistic that engineers with exceptional abilities will see a pathway to personal growth and development. Please give this position serious consideration. The Role We are currently seeking an Embedded Software Engineer for the development of electromechanical medical devices. The Embedded Software Engineer will be responsible for support of ongoing d...

The company has made some recent changes that give it the ability to pursue more projects and bigger projects. The key components including financing are now in place. Will guide how to provide mechanical engineering expertise from product prototype and development through commercialization. Will also learn how to provide product design guidance and consultation support on commercialized product. Good communication skills are important for client technical interface. ESSENTIAL DUTIES AND RESPONSIBILITIES • Provide continuing product support for manufactur...

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...

Top 3 Must Have Skill Sets: *Masters degree or PhD *Proactive to ask questions and think with experiences with analyzing/designing clinical trials *Strong statistical technical knowledge Good programming skills with SAS and R Employee Value Proposition: *The person in this role will work on a dynamic project working on multiple products (One product currently in the market and one in the development stage). Red Flags: *Only programming skills, No statistical skills *No experience analyzing clinical trial data *Only a bachelors degree TA Gen Med: inflammat...

Remote, 12-month contract with extension possible As the Lead Biomarker Statistician, you will be responsible for ensuring that biomarker data are generated appropriately to address relevant objectives such as the estimation of biological effects or the projection of clinical outcomes. This includes ensuring that studies are designed to answer specific and pertinent questions, that the analyses performed to account for various sources of variability and that the conclusions drawn are robust in the presence of multiplicity and confounding factors, especial...

The new Director of Engineering is looking for an EE with 10 or more years of experience. He can consider you for Principle Engineer, Group Supervisor for hardware, firmware, and software engineering (lots of embedded applications) and Systems Engineer. The company has several new projects starting and will be adding additional engineering talent. Other projects are being discussed to support other company's product development. A company has recently invested in this organization which will create funding for additional projects through business developm...

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...

Remote, 5-month contract, possible renewal based on business need The Senior Data Management Lead provides leadership and expertise in all aspects of Data Management. Develop and manage timelines for study data deliveries, including Go-Live, Interim Deliveries and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Data Management single point of contact to ensure that the contracted Data Management deliverables are being met specifically in terms o...

Regional Sales Director Position Overview: This position offers the right candidate the opportunity to manage a sales team and grow business with the resources of a growing and successful company. The Regional Sales Director will drive our expansion in a mix of currently served and new markets, lead a sales team, and ensure that all sales and management objectives are met and exceeded. Job Responsibilities: Become expert in our genome technology, products and services and be able to represent the company with healthcare providers, private and public insur...

Our client, a growing Phase I unit located in Monmouth County, is currently looking for a Principal Investigator! This is a full-time opportunity to join a great team! Previous experience with clinical trials is a plus, however the team will consider someone who has recently completed residency, and is interested in training for a career in clinical research. JOB SUMMARY The Principal Investigator (PI) promotes good clinical practices in the conduct of clinical investigations by assuring adherence to protocol requirements, protecting the rights and welfar...

The Molecular Biology Research Scientist should be an expert in using molecular tools to develop assays leading to viable products. They should have a deep understanding of underlying molecular processes and biochemical components within PCR or Next Gen Sequencing (NGS) assays, and be someone capable of diving deep into the data (requires in-depth understanding of the lab processes, for example to do root cause analysis of experimental outcome based on the data), and someone who can work independently. Key Responsibilities: Work with project leads and tea...

Full Job Description Job Summary: This is a leadership opportunity for a Board-certified Clinical Molecular Lab Director to play a central role in day-to-day management of key areas in the clinical laboratory including the development of a sustainable genomic knowledge management infrastructure, developing diagnostic WGS based services and expanding our menu for disease-focused tests. ________________________________________ Essential Duties and Responsibilities: Oversees all molecular testing, and related policies and communication of results. Ensures th...

Overall Purpose: Reporting into the VP of Regulatory Affairs, the Director of Regulatory Affairs and Pharmacovigilance is responsible for the creation, revision and review of various documents associated with clinical research. The documents may be submitted to Health Authorities worldwide to support clinical development and registration of our client's ophthalmic drug candidates. This position is also responsible for overseeing post marketing pharmacovigilance and promotional activities. Furthermore, the incumbent will demonstrate strong agility to chang...

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...

• Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, SDTM datasets, SDTM Define.xml, SDRG, Annotated CRFs) • Generating SDTM domains • Providing programming input to CRFs, SAPs, analysis file specifications, and tables, figures, and listings (TFLs) shells; • Contributing to the creation, maintenance, and validation of standards for outputs and SAS macros. • Working knowledge of Pinnacle 21 Basic Qualifications: • Bachelor’s degree in computer science, statistics, mathematics, life sciences or other relevant degre...

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...

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 operational delivery. Also responsible for driving process improvements within the project management function that supports larger...

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...

Remote long term FSP, SAS Programmer Responsibilities: Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications. Generating SDTM domains, ADaM datasets Providing programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells; Writing SAS programs to generate derived analysis datasets, perform analysis, and TFLs, performing ad hoc flexible and rapid programming arising from questions generated from...

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 ...

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...

Responsibilities 1. Develop and establish procedures for collecting, processing and analyzing biological specimens and other substances. 2. Performs and reports analytical tests, integrating and relating data generated by various clinical laboratory departments while making decisions regarding possible discrepancies. 3. Confirm abnormal results, verifying, executing and making decisions based on quality control procedures, and developing solutions to problems concerning the generation of laboratory data. 4. Establish and perform preventive and corrective ...

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...

Job Overview: The Project Manager fulfills the requirements of managing clinical trials (at the country or regional level, typically) to ensure timely delivery of project required objectives and timelines within the scope of the client agreements for assigned projects and the project budget. In doing so, the Project Manager is responsible for the cross-functional team’s compliance with the project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines and other applicable regulations....

(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 ...