Responsibilities Provide commercial regulatory knowledge, guidance, and risk assessments to cross-functional teams developing advertising and promotional materials, as well as senior management, that are aligned with corporate commercialization efforts. Collaborate with cross-functional teams in creating and reviewing promotional materials to ensure compliance with related corporate and regulatory requirements while meeting strategic promotional objectives. Conduct Regulatory promotional labeling and marketing compliance reviews of Clinical, Medical Affai...

Responsible for independently leading the preparation, alignment and formulation of a global regulatory submission strategy with direct accountability for US and/or Europe. Maintains a high level of regulatory knowledge and provides regulatory advice. Acts as single point of contact to FDA for products/projects. Liaises, negotiates and leads FDA and/or EMA interactions, including appropriate documentation of the interaction, decisions and outcomes with oversight from supervisor. Independently leads the preparation, coordination or monitoring of regulatory...

Will provide scientific and technical leadership at various stages of drug development including analytical method assessment, development, transfer, validation and troubleshooting of methods. The position will lead/support activities for research/early development programs, late-stage development programs, continued verification programs, process improvement projects and product stability Provide scientific and technical leadership internally as well as to members of the CMO analytical teams. Using technical expertise and management experience, set proje...

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 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 available to address...

Europe is switching from Medical device regulations (MDR) to medical device usability (MDU, human factors and usability) The Senior Regulatory Affairs Specialist must be able to demonstrate the following: • Develop strategies to help client companies obtain for 510K submissions to obtain FDA approval • Manage multiple projects and prioritize tasks on a day by day basis in order to meet project schedules • Use strong critical thinking skills to navigate the gray and to reach appropriate conclusions • Work effectively with customers in many functional areas...

Job Duties and Responsibilities: • Design, redesign, test, model and prototype medical devices. • Design electrical hardware circuits, utilizing analog components, micro-controllers, DSP and FPGA programming, serial communications, wireless communications and sensor applications. • Participate in design reviews and circuit risk analysis. • Work in a group setting to accomplish goals. Job Qualifications: • 10+ years of relevant electronic engineering experience, preferably within medical device industry or aerospace. • Circuit design, modeling, performance...

- 6 month remote potentially renewable contract; must be able to work pacific time zone hours CDISC experience required NDA submission big plus • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications. • Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files. • Perform quality control for SAS programs and other study documents (e.g., presentations and reports). • Maintain complete and auditable documentation of all progra...

- 6 month remote potentially renewable contract; must be able to work pacific time zone hours CDISC experience required NDA submission big plus • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications. • Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files. • Perform quality control for SAS programs and other study documents (e.g., presentations and reports). • Maintain complete and auditable documentation of all progra...

This position will be focused on ensuring GCP Compliance with global regulations, driving and implementing the Company’s Compliance Directives and supporting the Quality Management System to ensure Compliance and minimize risk in a regulated Pharmaceutical environment. The incumbent will plan, conduct, lead and/or participate in all GCP-QA (CRO, Sites, DM/STATs and PVG including systems) audit programs, including both internal and external GCP Audits. This position will also provide day-to-day support to the Head of Quality Assurance in Clinical Operation...

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...

*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 •...

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...

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...

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 Summary Supports the successful development, implementation, and improvement of manufacturing processes, to produce components and assemblies that meet customers’ requirements. Under the direction of the Operations Manager, and in cooperation with operations and engineering personnel, develops the necessary documentation, fixtures, tooling, and secondary process steps for the successful implementation, execution, and improvement of full scale manufacturing. Essential Job Functions • Knows and follows all safety requirements. • Under the direction of a...

(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 ...