|
Our job site is updated frequently. New jobs appear on the top of the Complete Job Openings Listing. However, please feel free to send your resume or an email inquiry to Jobs@JGBBioPharma.com. Then we can contact you if a good job fit arises.
Back to Jobs home
1) Bio-Statistician with SAS programming skills – 4 month contract (Pennsylvania) 939
2) Statistical Analytical Systems Programmer (Level III or Senior) 4 – 6 month contract (San Francisco Bay Area) E34PK
3) Statistical (SAS) Programmer – 6 month Contract position or Contract to Full Time (San Francisco Bay Area) T16GR
4) Senior Manager/Associate Director, Data Management – Full Time Position (San Francisco Bay Area) Y55SS
5) Senior Clinical Data Manager – Full Time Position (San Francisco Bay Area) NP55R
6) Clinical Data Manager – Full Time Position (San Francisco Bay Area) T71LT
1) Bio-Statistician with SAS programming skills – 4 month contract (Pennsylvania) 939
DESCRIPTION:
- The Statistical Programmer is responsible for providing significant programming support to the statisticians as part of the contribution towards the completion of statistical analyses (tables, listings and figures) and reporting of results of clinical studies. It includes Safety, Immunogenecity and Efficacy Analysis.
- In addition, other ad hoc analysis may have to be performed, based on the need, such as, analysis for Annual Reports, Publications, Information Brochure, Sales Aids, Poster Presentations, VRBPAC, CR and IR letters from regulatory agencies such as FDA, Drug Safety Monitoring Board (DSMB), exploratory analysis and other miscellaneous analysis as required by project/study teams.
- Assist in developing/building new tools or applications, developing and implementing new standards.
EXPERIENCE AND QUALIFICATIONS:
- Knowledge of SAS software, including macros programs development, and awareness of current features in SAS, especially in Base SAS, SAS/Stat and SAS/Graph.
- Knowledge of additional programming languages, such as, FORTRAN, C ++, Visual Basic, Oracle, etc., would be a plus.
- Aptitude for “Look and feel for software” would be desirable.
- Requires excellent programming skills, experience with regulatory submission (NDA, eBLA/BLA, CTD/eCTD), and the ability to work in a multidisciplinary team.
- Ph.D. with 4 years or more experience, Masters with 7 years or more experience in the pharmaceutical industry. The degree should be in Biostatistics, Statistics, or Mathematics.
To apply for a position send your resume to Jobs@JGBBioPharma.com
2) Statistical Analytical Systems Programmer (Level III or Senior) 4 – 6 month contract (San Francisco Bay Area) E34PK
DESCRIPTION:
- Provide programming support for NDA preparation
- Statistical programming to support ISE/ISS, ad-hoc analyses requested by medical/PK team for preNDA meeting and NDA submission,
- Independent validation of analysis files and key Tables/Figures produced by CRO (Contract Research Organization), including resolution of discrepancies in a timely manner,
- Validate that SDTM/AdAM specifications and data files for key studies meeting the submission requirements as outlined in cDISC guidelines
- Ensure the edit check specification and data quality for on-going clinical study
EXPERIENCE AND QUALIFICATIONS:
- At least 5 years of Biopharmaceutical or CRO experience.
- Regulatory submission (NDA/BLA) experience.
- Fluent in SAS programming is mandatory, particulary in CDISC/SDTM
- Must have previous experience filing eCTD drug registration with FDA
- Familiarity with the preparation of regulatory documents such as Integrated Safety Summary and Integrated Summary of Efficacy is required.
- Excellent verbal and written communication skills.
- Collaborative skills in team settings are required.
- Must be able to work independently and be proactively resourceful
- In house position, local candidates only
To apply for a position send your resume to Jobs@JGBBioPharma.com
3) Statistical (SAS) Programmer – 6 month Contract position or Contract to Full Time (San Francisco Bay Area) T16GR
DESCRIPTION:
- Writing SAS programs from instructions provided by Biostatisticians and Statistical Programmers to create data sets, tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications
- Utilize SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
- CDISC SDTM and AdaM models and transforming raw data into these standards
- Create all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE
- Work with all types of safety data and coding dictionaries (MedDRA and WHODRL) commonly used by the pharmaceutical industry
- Work in a team environment providing technical leadership and solving clinical trial reporting problems of moderate to high complexity within budget and customary time line constraints while assuring high quality standards
- Perform quality control checks of SAS code and output produced by other Statistical Programmers
EXPERIENCE AND QUALIFICATIONS:
- B.S. or M.S. in Biostatistics, Statistics, Computer Science, or a related field and a minimum of 3 years of SAS and relevant pharmaceutical industry experience
- Knowledgeable regarding software validation and system development life cycle concepts
- Oncology experience preferred
- Expertise in SAS/BASE, SAS/STAT, SAS/MACRO Competence with SAS/GRAPH, SQL
- Experience with regulatory reporting and submissions; involvement in NDA or BLA is preferred
- Understanding of regulatory requirements and considerations (e.g. GCP, ICH, 21CFRpart11, CDISC)
- Excellent organizational, technical, and interpersonal skills
- Ability to work independently and act with initiative to address issues
To apply for a position send your resume to Jobs@JGBBioPharma.com
4) Senior Manager/Associate Director, Data Management – Full Time Position (San Francisco Bay Area) Y55SS
DESCRIPTION:
The Senior Manager, Associate Director is responsible for overseeing all Data Management (DM) operational activities ensuring compliance with the corporate timeline and scope of work outsourced to the DM service provider (SP) and coordinating activities from other external vendors that may also provide study data. This includes but is not limited to vendor and technology evaluation, qualification and selection, budget assessment and contract negotiations, training and oversight for all DM services from study start-up through study close-out and final reporting. This position reports to Head of Biometrics.
Specific Duties
- Participate in vendor and technology (e.g., EDC) evaluation, qualification and selection. Involved in RFP development and contract negotiation, as needed.
- Oversee and manage all DM related activities outsourced to DM SP as well as other external data sources (e.g. central and/or specialty labs, IVR vendors, etc.) from study start-up through study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time and within budget.
- Participate with the Study Operations Teams (SOTs) for all study activities, and lead all DM functional activities using established FGN templates/processes as applicable (e.g. FGN DM standards include CRFs, Completion Guidelines, edit check specifications, metric/status reports, transfer agreements, DMP template, medical coding conventions, etc.).
- Provide operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards while ensuring established standards.
- Review study data for completeness and general clinical sense. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations.
- Develop and manage the data review plan for each assigned study, including maintenance and tracking of findings from all team members through issue resolution and involving the data vendors as needed.
- Responsible for ensuring SOP and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical Data Management Practices internally and with DM vendors via regular process auditing.
- Participate in the development of SOPs, working practices, DM standards, policies and Clinical Development process improvement supporting clinical data management activities.
- Ensure the receipt and proper filing, security and archiving of study related data, both paper and electronic media, at all times.
- Able to cultivate effective and productive working relationships with colleagues, subordinates, vendors and management. Able to use clear judgment to solve problems and to escalate issues with proposed solutions, as necessary.
- Assist the Head of Biometrics in reviewing competitive bids related to Data Management vendor and in deciding on awarding projects to competing CROs
- Assist the Head of Biometrics in providing standards as pertains to Data Capturing on the Project level
- Assist the Head of Biometrics in Assessing the Data Management capabilities for competing CROs
- Provide Mentorship to Junior Data Managers
EXPERIENCE AND QUALIFICATIONS:
- Bachelor’s degree in a relevant scientific discipline or equivalent
- Minimum of ten years of relevant clinical experience in the pharmaceutical, biotech and/or CRO industries, or equivalent
- Skills present in core data management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries). CCDM Certification a plus
- Knowledge and experience with various clinical databases (e.g., Clintrials, Oracle Clinical, SAS) and key technologies (e.g., EDC, Scanning/Imaging, IVRS/IWRS)
- Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required
- Excellent communication, written and interpersonal skills
- Self sufficient and able to work with minimal oversight
- Demonstrate leadership skills and the ability to lead teams and motivate team members, as needed
- Able to prioritize and handle multiple tasks and studies simultaneously
- Able to manage direct staff, as needed. Ability to develop project management objectives and manage performance reviews, as needed
- Proficiency with MS Word, Excel, Outlook, and PowerPoint, SAS programming a plus
- Must be willing to travel as required
To apply for a position send your resume to Jobs@JGBBioPharma.com
5) Senior Clinical Data Manager – Full Time Position (San Francisco Bay Area) NP55R
DESCRIPTION:
The Senior Clinical Data Manager is responsible for overseeing Data Management (DM) operational activities, ensuring compliance with the corporate timeline and scope of work outsourced to the DM service provider (SP) and coordinating activities from other external vendors that may also provide study data. This position reports to Head of Biometrics and may report to a Senior Manager, Data Management.
Specific Duties
- Oversee and manage DM related activities outsourced to DM SP as well as other external data sources (e.g. central and/or specialty labs, IVR vendors, etc.) from study start-up to study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time and within budget.
- Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts
- Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications
- Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, and CRF (eCRF) completion / monitoring conventions
- Develop and test data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities
- Participate with the Study Operations Teams (SOTs) for all study activities, and lead all DM functional activities using established FGN templates/processes as applicable.
- Provide operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards.
- Review study data for completeness and clinical sense. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations.
- Develop and manage the data review plan for each assigned study, including maintenance and tracking of findings from all team members through issue resolution and involving the data vendors as needed.
- Ensure the receipt and proper filing, security and archiving of study related data, both paper and electronic media, at all times.
- Able to cultivate effective and productive working relationships with colleagues, subordinates, vendors and management. Able to use clear judgment to solve problems and to escalate issues with proposed solutions, as necessary.
EXPERIENCE AND QUALIFICATIONS:
- Bachelor’s degree in a relevant scientific discipline or equivalent
- Minimum of 5 years of Data management experience in the pharmaceutical, biotech and/or CRO industries, with experience in managing data from Phase III clinical trials.
- Skills present in core data management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries). CCDM Certification a plus
- Knowledge and experience with various clinical databases (e.g., Clintrials, Oracle Clinical, SAS) and key technologies (e.g., EDC, Scanning/Imaging, IVRS/IWRS)
- Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required
- Phase III experience
- Excellent communication, written and interpersonal skills
- Self sufficient and able to work with minimal oversight
- Demonstrate leadership skills and the ability to lead teams and motivate team members, as needed
- Able to prioritize and handle multiple tasks and studies simultaneously
- Able to manage direct staff, as needed. Ability to develop project management objectives and manage performance reviews, as needed
- Proficiency with MS Word, Excel, Outlook, and PowerPoint, SAS programming a plus
- Must be willing to travel as required
To apply for a position send your resume to Jobs@JGBBioPharma.com
6) Clinical Data Manager – Full Time Position (San Francisco Bay Area) T71LT
DESCRIPTION:
The Data Manager is responsible for managing the efficient collection, processing, and review of data from clinical trials. This position serves as a technical resource in the conduct of Phase I to Phase III Clinical Trials.
- Directly manages staff and conducts recruitment and on-boarding; Oversees the work of direct reports to ensure on-time, on-target and within-budget results
- Conducts regular one-on-one and any other staff meetings to ensure timely communication with direct reports
- Select and implement internal thesaurus management system and select and oversee external thesaurus management vendor
- Ensure consistency of classification within a study and across studies for the same compound
- Set global classification conventions
- Author study specific thesaurus management plan with classification conventions; Perform thesaurus classification of adverse events to MedDRA
- Perform thesaurus classification of concomitant medications to WHO drug
- Create and maintain thesaurus management SOPs, work instructions and template; Perform SAE vs AE reconciliation
- Perform clinical data review consistency between medical history, adverse event and concomitant medication
- Set global lab data conventions
- Author study specific lab data management plan
- Collect local lab ranges; Assign local lab ranges to local lab data and Perform conversion of local lab data to standardized reporting units
- Select and oversee central labs
- Author external lab data management plans and specifications
- Receive test and production lab data transfers; Review central lab data transfers
- Create and maintain lab data management SOPs, work instructions and templates
- Perform clinical data review consistency between lab data and adverse event data
- Provide technical assistance to the CDM, clinical, safety, medical and biostatistics departments – Thesaurus, central lab, and local lab management
EXPERIENCE AND QUALIFICATIONS:
- Excellent oral and written communication skills.
- Understanding and familiarity of the drug development process.
- Knowledge of execution of Phase I-III Clinical Trials.
- Excellent knowledge of MedDRA and WHO drug coding dictionaries required
- Basic knowledge of SAS dataset structure required, working knowledge preferred.
- Excellent knowledge of local and central lab data required
- 8+ years clinical development experience required.
- 3 years management experience required.
- Working knowledge of paper based/ fax based and electronic data capture (EDC) processes and software.
- Working knowledge of adverse event and concomitant medication classification processes and software.
- Master’s Degree and 5+ years clinical development experience required; or
- Bachelor’s Degree and 10+ years clinical development experience required. or
- No degree and 15+ year clinical development experience required.
To apply for a position send your resume to Jobs@JGBBioPharma.com
|
