The Post Market Surveillance Manager will manage day-to-day operations of Risk Management staff: review staff work output, prioritize staff activities to assure the risk support deadlines for design control projects, design change projects and improvement projects are met, and oversee staff training and development. Essential Functions: Oversee the management of Risk Management Program: Create IVD medical device benefit/risk profiles based on medical opinion and literature, Ensure Risk Management Files (RMF) support safety and effectiveness of IVD medical...

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...

Our client, a growing international pharmaceutical/biotech company is looking for an experienced Medical Writer to join their team! This is a full-time opportunity with competitive compensation and benefits package. The key responsibilities in this position will be to perform medical writing tasks for clinical development project related activities including but not limited to preparation of Clinical Development Plan (CDP), Clinical Trial Protocol(CTP), Clinical Trial Reports (CTR), Layperson Summary (LPS), Investigator Brochure (IB), Regulatory response ...

- 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...

Planning, writing, and reviewing relevant clinical documents such as study protocols, analysis plans, reports, and regulatory documents. These will be accomplished by working in close partnership with other scientists including Biomarker Science, Clinical Science, Clinical Operation, Non-clinical Science, Pharmacovigilance, Regulatory...

Remote Macro Utility SAS programmer, ongoing FSP We have a new FSP opening to help support our stat programming infrastructure team. This involves working in our SAS macro development team to design, develop, validate, and maintain departmental SAS macros in accordance with established procedures. Several qualifications below are similar to our routine calls for study support candidates, since we feel it is critical that our infra team has direct experience as study and submission programmers in addition to macro development, so they better understand the...

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...

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...

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...

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...

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...

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...