TheCytogenetics/FISH Technologistis responsible for performing all aspects of testing in a clinical Cytogenetics/FISH Laboratory. They evaluate and introduce new material, methods, and equipment to help determine the feasibility and/or adaptability for clinical cytogenetic /FISH studies. They assist supervisors in the development of new technologies and participate in documenting and implementing Quality Assurance (QA)/ Quality Control (QC)/Quality Inventory (QI) procedures. Performs scanning and microscope analysis of chromosomes and interphase nuclei fo...

this individual will have responsibility for providing CMC regulatory leadership and strategy required to achieve regulatory approvals, collaborating closely with multiple scientific, technical, quality, and commercial areas within the company and with external contract manufacturing organizations (CMOs). This position provides knowledge, understanding, interpretation, and utilization of regulatory guidances and regulations, as well as industry and government agency best practices and trends. Responsibilities: Lead, develop, and implement CMC regulatory s...

The Manager Drug Regulatory Affairs is responsible for planning, managing and tracking regulatory documentation, and successful preparation and filing of submissions (DMF, ANDA, NDA) in the required electronic format. This role serves as the system owner for regulatory information tools and technologies, and develops processes to ensure submission are complete and comply with applicable regulatory requirements, in a fast-paced environment. This individual collaborates with cross-functional teams (RA, QA, IT, etc.) to bring excellence in regulatory plannin...

The Lead Biostatistician for product facing work is responsible for leading statistical activities of clinical studies. Works closely with cross-functional team members to ensure their clinical studies are appropriately planned, have the required statistical power for success, comply with Regulatory requirements and Amgen standards, and maintain statistical, as well as operational, integrity throughout the life of the study. Works closely with the Global Statistical Lead to ensure their study aligns with the overall product strategy. Also works closely wi...

Description: *Long-Term, Remote FSP role The DBA is responsible for the development and implementation of optimal solutions to transform, integrate, store, secure, process and update large real-world healthcare data assets for use by statistical programmers, data scientists and other data analysts. Relevant database administration experience includes: • Extensive knowledge of developing data pipelines using real-world healthcare data including claims and electronic medical records. • Experience with one or more of the following commercial databases: Marke...

*Initial 6-month contract, remote, and potentially renewable Summary We are looking for experienced statisticians who can quickly step into hands-on, detailed analyses with minimal training. Candidates need to be comfortable working in a fast-paced SAS® programming environment on complex studies across many therapeutic areas, and have at least 5 years of pharmaceutical industry experience. CRO experience is preferred. Typical tasks include (but aren’t limited to): • Writing/reviewing Statistical Analysis Plan text and Table, Listing, Figure (TLF) shells •...

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

A highly visible position repsponsible for creating and executing program stategy for research organization to lead programs to IND and clinical development. Responsibilities: • Responsible for creation, management, and communication of Integrated Development Plan • Lead cross-functional communication, drive strategic and operational alignment with the program team, functional leads, and Executive Leadership Team • Work with a cross functional team to prepare study designs, manage budgets and oversee the study from initiation to report generation. • Ident...

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 healthcare events in large databases (millions of record...

Contract Amgen Thousand Oaks California Accepting Candidates *Long-Term, Remote FSP role The DBA is responsible for the development and implementation of optimal solutions to transform, integrate, store, secure, process and update large real-world healthcare data assets for use by statistical programmers, data scientists and other data analysts. Relevant database administration experience includes: • Extensive knowledge of developing data pipelines using real-world healthcare data including claims and electronic medical records. • Experience with one or m...

1. We now have so much more SAS programming to do, all building off the SAS codebase, that we now need someone suited to that role. As well as someone with more extensive experience with OMOP and ETL’s. 2. Candidates must have excellent SAS programming skills and the ability to implement complex data step logic and SQL. Additional proficiency with Python is highly desired, as well as ability to implement and troubleshoot complex ETL and QC programs. 3. + OMOP should be included as a key capability....

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...

- 12 month remote renewable contract Top 4 Must Have Skill Sets: * SAS experience * Pharma industry experience * Experience with claims databases * Statistical Analysis experience 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 and SAS too...

We are seeking AP/CP board certified Pathologist and are pleased to offer this exceptional opportunity in our rapidly growing hospital-based practice in Southern, IL. This practice will involve central practice in one hospital and support of other satellites hospitals. The successful candidate must be board certified in Anatomic and Clinical Pathology. Subspecialty training or certification is highly desired but not required. It is preferred that candidates currently hold Illinois medical license or be eligible. The position will have solo coverage and re...

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 ...

- 12 month remote renewable contract 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, supported by examples Demonstrated proacti...

The Senior/Principal Biostatistician works independently in the production and quality control of analysis plans, reports, derived datasets, tables, listings and figures, provides statistical advice to clients and fulfills the project primary role within a designated project team. Key Accountabilities: Coordinate and lead a project team to successful completion of a project within timelines and budget Interact with clients as key contact with regard to statistical and contractual issues Perform QC of derived datasets, tables, figures and data listings pro...

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...

We are currently looking for a Medical Director/ Senior Medical Director specializing in Oncology to join our client's global Medical Affairs team. We are open to Oncologists (board certified US or foreign board certified) who are interested in moving their career into industry, helping to develop and bring out new drugs for cancer patients. These positions are home-based with minimal travel, and can be based in either the US or Canada. Working in a fast-paced, client-focused global environment, our Medical Directors play a pivotal role on our client's pr...

We are currently looking for a Medical Director/ Senior Medical Director specializing in Oncology to join our client's global Medical Affairs team. We are open to Oncologists (board certified US or foreign board certified) who are interested in moving their career into industry, helping to develop and bring out new drugs for cancer patients. These positions are home-based with minimal travel, and can be based in either the US or Canada. Working in a fast-paced, client-focused global environment, our Medical Directors play a pivotal role on our client's pr...

As a FISH - Laboratory Supervisor, you will have the overall responsibility for the planning, coordination, evaluation, and supervision of all technical and/or operational activities and personnel in the department. You will be responsible for performing duties to meet quality assurance, safety and accreditation requirements in the laboratory. The FISH - Laboratory Supervisor is also responsible for helping in the implementation of all area procedures and operations as well as ensuring that metrics established to measure quality, production and efficiency...

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...

• Provide statistical guidance, review, and contribution to SAPs; TFL shells; DMC Charters; SDF specifications (SDTM and ADaM); randomization specifications; other key-study related documentation, protocol deviations, data quality review, and other communications • Attend and be a contributor at Clinical Study Team Meetings • Attend meetings for and provide statistical input into cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review • Initia...

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

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

- 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...

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....

Our client is currently hiring! MID WEST, WEST COAST and EAST COAST home-based positions available. Home based CRA opportunities with a growing Pharmaceutical Company sponsor, with a focus on CNS! Travel approximately 75% and CRAs carry 1-2 protocols maximum. Experience with remote monitoring a plus! Excellent Compensation packages available! Please email me for details!...