Our client, a growing successful global biotech/pharma company is currently hiring! The Senior Medical Director (or VP, flexible based on candidate's experience) will be responsible for providing directions and leading relevant communication and decision to determine clinical development as well as medical strategy for their product launch. You will play a key role in the work required to receive a marketing authorization of our drug, such as interaction with regulatory agencies, data interpretation and communication internally and externally, management ...

Remote W2 hourly only, leading pharmaceutical client needing remote Manager of Clinical Systems (IRT) Interactive Response Technology: 12-month contract with potential to renew, fully remote The Manager, Clinical Systems (IRT) will work with a cross-functional team of internal stakeholders (including but not limited to: Clinical Study Management, Supply Chain and Data Management functions) and technology suppliers to support the implementation and maintenance of interactive response technology (IRT) solutions to support a clinical trial. The Manager, Clin...

The senior programmer will be responsible for manipulating large databases and generating reports to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS and SQL programming skills and the ability to implement complex 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 building patient cohorts and evaluating patient healthcare events in large databases and using observational research methods...

Long term FSP engagement Responsibilities: • Support targeted epidemiologic research in specific disease areas, including systematic literature reviews, NH of disease for business development and early development indications • Contribute to registry strategy for early development and early clinical indications to support BOI for clinical endpoints or NH of disease needed for regulators and clinical development • Lead and execute evaluation of available registries and other data sources related to BOI or NH • Determine potential use of RWE historical cont...

Remote, 12-month contract with potential to renew Senior Statistical Programming Consultant Responsibilities: Provide statistical programming support to generate SDTM and ADaM datasets, tables, listings, and figures for individual studies and ISS/ISE to FDA, EMA, and other worldwide regulatory agencies Participate in the review of statistical analysis plans and TLF specifications Review or annotate CRFs for SDTM mapping, review/author SDTM/ADaM dataset specifications Review, and comment on CRFs, vendor data transfer specifications (DTS), edit checks and o...

- Long-term, remote, FSP support role for General Medicine TA: The senior programmer position will be responsible for manipulating large databases and generating reports to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS and SQL programming skills and the ability to implement complex 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 building patient cohorts and evaluating patient healt...

Remote Clinical SAS programmer, FSP Job Description Qualifications: • 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 • Experience in regulatory safety reporting (DSUR/PBRER/PSUR) • Experience in performing safety data integration and safety reporting to support signal detection and risk evaluation • Experience in working with MedDRA and WHODrug coding dictionaries and customized Standardized MedDRA Queries (SMQs) • Experience in macro/utility ge...

Qualifications • 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 • Hands-on experience in study integration (ISS/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 creating or providing significant input into spec...

- Long-term, remote, FSP support role: The Senior Programmer position specializing in data visualization will be responsible for developing utilities, applications and reports using R and R Shiny to enable analysts to explore real world healthcare data assets. The programmer will interface with non-technical and technical people to gather requirements, present iterations of development, and write documentation. Candidates must have previous experience as an R Shiny developer, with R, SAS, SQL, and/or Python skills desired. Candidates must be comfortable w...

$15k SIGN ON BONUS- ASCP preferred and or proof that you are sitting for exam. Base salary give or take $43-47/hr - $15k SOB - THEY WILL NOT PAY UP FRONT! Shift-Mon-Fri 8am-4pm - They can be flexible to an extent! Shift differential: 2nd shift is 10% - Weekends are 15% Vaccine is NOT required! Upon submitting candidates, we need their degree, transcripts, Certification - If the candidate cannot get it to you right away, send anyway. But they MUST have this info before even considering the candidate! interview Process: Virtual Onsite/Slide Test...

Molecular Pathologist - 23-00071 • MD/DO and/or Ph.D • ABP or ABMGG Board eligibility or certification...

Hematopathologist – 23-00070 • Medical Doctor (or equivalent medical professional degree) with hematopathology fellowship training. • Board Certification in AP or AP/CP by the American Board of Pathology or American Osteopathic Board of Pathology. • Hematopathology board certification or board eligible. Subspecialty training in molecular pathology is desired. • Hold or eligible to obtain unrestricted medical licensure in Arizona and other states. • Maintain required CME and other educational requirements for state licenses....

Technical Laboratory Director – Genetics – 22-00152 • Doctoral degree in Genetics or related field and completion of clinical fellowship training in Laboratory Genetics and Genomics or in Clinical Molecular Genetics and Genomics (preferred) and/or Clinical Cytogenetics and Genomics. • Minimum 3 years' experience in clinical laboratory in the appropriate discipline(s). • Proven ability to work with others. • Proven team building skills and excellent communication skills. • Strong organizational skills. • Knowledge of laboratory information systems. • Stron...

Histotechnologist – 23-00077 • Day shift – Start time varies! • $20k SIGN-ON BONUS! • Experience within a Derm lab is required. • MUST have both ASCP and FL State License! • Required Education and Experience: Associate in Science degree in related science field along with successful completion of an approved formal training program in Histology. Active state of Florida license as a Histotechnologist. Registry with HT or HTL ASCP. • Preferred Education and Experience: bachelor's in science. A minimum of one year experience as a Histotechnologist to include...

Medical Technologist – Microbiology – 23-00076 • $5k sign-on! • Day shift – Start times are flexible and vary! • MUST have ASCP AND FL State License • Associate's Degree or Bachelor's Degree in Medical Technology or related Science degree along with the successful completion of an approved formal training program in Medical Technology. • Preferred Education and Experience: Experience in a clinical laboratory setting involving the analysis of blood, tissue and body fluids utilizing automated equipment and specialized instrumentation while performing numero...

Remote, 12-month contract with potential to renew Senior Statistical Programming Consultant Responsibilities: Provide statistical programming support to generate SDTM and ADaM datasets, tables, listings, and figures for individual studies and ISS/ISE to FDA, EMA, and other worldwide regulatory agencies Participate in the review of statistical analysis plans and TLF specifications Review or annotate CRFs for SDTM mapping, review/author SDTM/ADaM dataset specifications Review, and comment on CRFs, vendor data transfer specifications (DTS), edit checks and o...

Both positions support Matt Ness' DV compound team, phase 1-3 TLF production and delivery as well as integration activities. Remote SAS programmer, West Coast, FSP ongoing work opportunity Qualifications • 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 • Hands-on experience in study integration (ISS/ISE) • Strong communication skills, both written and verbal • Demonstrated attention to detail and...

Must haves: a strong R programmer with extensive experience in the OHDSI OMOP common data model. He/she should also be well-versed in RWD/RWE research, Remote 12 month contract Remote, 12-month renewable contract Description As a Sr programmer/analyst, Real-World Data and Analytics, you will conduct hands-on programming (expert level in R, proficient in SQL) in supporting our real-world data & analytics needs under the supervision of our Director HEOR analytics scientists. Responsibilities: Respond to HEOR Director’s request timely Understand query, analy...

Remote HEOR Analyst Responsibilities: • Conduct data queries and analyses using in-licensed real world data assets to support the product portfolio and development therapeutic and disease areas; areas of research may include disease prevalence, disease burden and progression, healthcare resource utilization, and treatment patterns in ‘real world’ populations • Develop and implement efficient SAS programs for assigned projects • Assist in development of protocols/analysis plans • Generate analytic reports, tables, and graphics to communicate project findin...

Target profile is 12-15 years experience; although this position is focused on hands-on programming, experience as a lead is preferred Prefers if candidates are located in Pacific Time Zone because they need afternoon coverage. If candidates can commit to core 9am-4pm PST hours M-F, they can be located in other time zones. Please confirm with candidates. Remote, 12-month contract with potential to renew Senior Statistical Programming Consultant Responsibilities: Provide statistical programming support to generate SDTM and ADaM datasets, tables, listings, ...

Job 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 Leverages all licensed RWD avail...

Remote, 12-month contract with potential to renew The Lead Biostatistician for data visualization will work to support numerous development projects to enhance capabilities in R and R-shiny. The SLS works closely with other statisticians to develop tools to meet product team needs. This SLS works closely with the members of various initiative leads and Global Statistical Leads to ensure tools developed can support study conduct and analysis efficiently Core Responsibilities: • Provide statistical guidance, review, and contribution to protocols, SAPs; TFL ...

Remote, 6-month contract with potential to extend long term Principal Statistical Programmer (SAS) Our client is dedicated to developing breakthrough therapies for neurodegenerative diseases through a deep commitment to degeneration biology and principles of translational medicine. We are seeking to recruit an experienced principal statistical programmer. The candidate will have the opportunity to help shape the client’s data and programming infrastructure, gain an in-depth understanding of drug development in a fast-moving industry environment and subjec...

- Long-term, remote, Sr. Statistical Programmer (RWD) 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 eye for outliers and errors. Prior experience building patient cohorts and evaluating patient he...

- Long-term, remote, Sr. Statistical Programmer (RWD) 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 eye for outliers and errors. Prior experience building patient cohorts and evaluating patient he...

Long-Term, Remote Principal Statistical Programmer Qualifications: 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...

Long-Term, Remote Principal Statistical Programmer Qualifications: 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...

Long-Term, Remote Principal Statistical Programmer Qualifications: 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...

Long-Term, Remote Principal Statistical Programmer Qualifications: 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...

Long-Term, Remote Principal Statistical Programmer Qualifications: 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...

Sr. Statistician of Quality Assurance will serve as a key expert supporting the 2022 Quality Metrics Improvement project. Responsibilities include: Utilizes statistical tools and methods to assess the behavior of quality performance metrics and determine adequate metric definition based on data and process knowledge. Apply analysis tools to make predictions about future outcomes and in multiple scenarios. Interprets and applies data in analyses and explains findings to project leads. Assists business with solutioning e.g. SPC techniques, Predictive models...

Sr. Statistician of Quality Assurance will serve as a key expert supporting the 2022 Quality Metrics Improvement project. Responsibilities include: Utilizes statistical tools and methods to assess the behavior of quality performance metrics and determine adequate metric definition based on data and process knowledge. Apply analysis tools to make predictions about future outcomes and in multiple scenarios. Interprets and applies data in analyses and explains findings to project leads. Assists business with solutioning e.g. SPC techniques, Predictive models...

Sr. Statistician of Quality Assurance will serve as a key expert supporting the 2022 Quality Metrics Improvement project. Responsibilities include: Utilizes statistical tools and methods to assess the behavior of quality performance metrics and determine adequate metric definition based on data and process knowledge. Apply analysis tools to make predictions about future outcomes and in multiple scenarios. Interprets and applies data in analyses and explains findings to project leads. Assists business with solutioning e.g. SPC techniques, Predictive models...

- Long-term, remote, Sr. Statistical Programmer (RWD) 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 eye for outliers and errors. Prior experience building patient cohorts and evaluating patient he...

- Long-term, remote, Sr. Statistical Programmer (RWD) 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 eye for outliers and errors. Prior experience building patient cohorts and evaluating patient he...

- Long-term, remote, Sr. Statistical Programmer (RWD) 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 eye for outliers and errors. Prior experience building patient cohorts and evaluating patient he...

- Long-term, remote, Sr. Statistical Programmer (RWD) 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 eye for outliers and errors. Prior experience building patient cohorts and evaluating patient he...

Remote FSP, long term, 40 hours work a week, ongoing Qualifications: • At least 8 years of hands-on experience in Stat Programming with no employment gaps. 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, s...

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...

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

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...

Relocation assistance $2,500 Requirements: • ASCP Certification CT (ASCP) required • Florida License. Eligible...

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...

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...

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 ...