TechD ata is looking for Clinical Programmer (Oracle Clinical),Bios tatistician(Clinical Studies and Outcome Research), SAS Programmer/Statistical Programmer (Some can be telecommuting), Sr. Clinical Data Manager, Drug Safety Specialist, Outsourcing manager for our pharmaceutical clients in Central NJ and Northern NJ. Please see below requirements and send your resume to: . TechData is a leading provider for temporary and permanent positions in the pharmaceutical industry. TechData offers the most competitive pay rate and benefits in clinical research and consulting services.
Biostatistician for Outcome Research
The EBM biostatistician provides statistical expertise for all observational research project sponsored by the US Evidence Based Medicine (EBM) in protocol development, Statistical Analysis Plan (SAP) preparation and study report. The role needs to ensure that appropriateness of study design, sample size and statistical methodologies are used and adherence to the established standards and SOPs. The role manages the timely execution of statistical and research methodological components of EBM study protocols in order to meet project objectives and has a thorough understanding of current requirements for statistical standards.
Roles/Responsibilities Utilize statistical knowledge of and expertise to provide statistical support for EBM studies, with a main focus of real-world observational studies, database examples:
1)US medical and pharmacy claims databases (e.g. MarketScan); 2) US medical record databases (e.g. GE Healthcare); 3) US government public use databases (e.g. NHANES, MEPS) Participate in study concept, protocol and SAP development and ensure appropriateness of study design, sample size and statistical methodologies proposed. Specify the structure of the datasets that will be delivered for statistical analysis to ensure that the structure follows any existing company standard for databases pooling. Mock-up, review, and approve tables, listings and graphs specifications. Actively participate in project/study team meetings Establish/negotiate timelines for completion of study-related statistical activities. Ensure the study timelines are met. Conduct observational data analysis, include data management, statistical programming, interpretation of analyses results, and write-up/review the corresponding sections of EBM study report. Produce analysis datasets, listings, tables, and figures for research projects, according to specifications, while maintaining documentation and complying with pre-defined project / study standards. Provide oversight of the biostatistics-related activities for EBM studies subcontracted to a CRO: Oversee the CROs work on the preparation of analysis plans, development and validation of computer algorithms for inferential analyses, statistical writing of study reports, and other outsourced analyses as appropriate. Perform quality control procedures to ensure that statistical deliverables conform to the requirements outlined in the SAP Skills: Working knowledge and experience with bio statistical analysis and SAS programming. Excellent oral and written communication skills in English are a must. Prior work experience in epidemiology, health economic and outcome research, or clinical research area is a plus. Specific experience and understanding of outcomes research, drug development is an asset Familiarity with observational databases desirable; database examples US medical and pharmacy claims databases (e.g. MarketScan) US medical record databases (e.g. GE Healthcare) US government public use databases (e.g. NHANES, MEPS)
Ph.D. or MS in Statistics or related field Minimum 5-year experience in pharmaceutical research or equivalent
Biostatistician for Clinical Studies
Work closely with clinicians, programmers, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review.
Work with the clinical study team on study design, development and/or review of clinical study protocols.
Develop and/or review statistical analysis plans, including Table/listing/figure shells, and final study report for clinical studies; perform post-hoc statistical analyses as needed.
Work with the project statistician and clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality.
Oversee CRO programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, ensure the quality of CRO deliverables.
May work with the Health Outcome team on the design/analysis/validation of projects.
May work on submission teams as a statistician and/or a programmer.
QUALIFICATIONS NEEDED:
Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 3 years of experience in the pharmaceutical, CRO or biotech industry.
Strong SAS programming skills.
Oncology experience is highly preferred.
Good technical writing skills.
Good communication skills (verbal and written).
Strong teamwork ability/commitment and individual initiative.
Strong organizational skills with ability to effectively manage multiple projects.
we need is an experienced statistician who can do SAS programming at the same time can clearly interprete statistical concept and results to non-statisticians and key medical opinion leaders .
Sr. Statistical/SAS Programmer (Some position can be telecommuting)
Main purpose of the job:
To support the Biostatistics team by carrying out and overseeing programming activities of statistical programmers and external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies. Contributes to the overall efficiency and best practice running of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.
Main duties/responsibilities:
1. Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), electronic submissions and other internal and external requests (e.g., publications). Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files). Working with external vendors in order to develop or monitor the content and structure of SAS data sets.
2. Developing and maintaining SOPs, SWPs and other related technical documents, providing input to the Database and CRF Development, creating edit check programs and providing feedback to the Data Management. Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents. Determining and researching SAS software upgrades and related systems and addressing maintenance issues.
3. Managing and developing team, maintaining standards for programming activities, and guiding/coaching Statistical programmers.
4. Working independently to accomplish tasks and goals defined by supervisor. Attending required training and meetings and bringing in new ideas to improve the programming process.
Responsibilities weighting may change significantly based on the incumbent and their assigned areas of responsibility.
Qualifications and education required:
Minimum of Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related science discipline. Masters preferred.
Experience required:
Minimum 5 years experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment. 7+ years experience preferred.
Some project experience in a pharmaceutical/CRO programming environment or demonstrated significant leadership of SAS programming activities in a clinical pharmaceutical/CRO environment.
Skills and aptitude required:
Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office.
Proven experience with Unix and Windows operating systems.
Understanding of the software development life cycle.
Understanding of FDA guidelines.
Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
Applies good judgment and demonstrates initiative to resolve issues.
Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment, managing that team as required.
Clinical Programmer (Oracle Clinical)
Responsibilities will include, but are not limited to: • Develop, program, test and maintain clinical trial databases and data entry screens using Oracle Clinical or Central Designer in accordance with standards • Review computer validation/edit ch ecks for in-house and outsourced studies • Develop, program, test and maintain computer validation/edit checks in PL-SQL and/or SAS • Develop, program, test and maintain data review listings in Oracle Clinical, Inform, Jreview and/or SAS for data review pu rposes • Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and standards • Validate peer programming • Participate in and lead team meetings when appropriate • Act as pr imary CRO contact, when necessary, to ensure that standards are implemented in all studies • Provide technical expertise and support to Data Management team • Control access to database and perform snapshots, database lock and freeze activities • M ake data, including interim data, available to company personnel and regulatory agencies when required • Perform post processing of data extracts in accordance with standards to be delivered to Biostatistics • Routinely interface with cross-functio nal team members • Influences other functions and represents as DBO technical expertise • Internal team leader who decides best course of action • Coach and advise junior programmers to identify problems and solutions 1. Manage outside CROs and consultants : • Review clinical programming activities and costs in contracts • Assess CRO data management systems for regulatory compliance • Interact with CROs in the design and development of databases that are compatible with company needs • Monitor progress of cl inical programming activities in CROs • Participate in regular team meetings and provide input when appropriate 2. Other Activities • Participate in the development of clinical programming SOPs and the development/optimization of clinical programming proce sses from study start up to database lock. • Routine interface with cross-functional team members in creating an appropriate database, data quality assurance, and support of data cleaning activities • Direct responsibility for supervising and training juni or clinical programmers in the performance of their duties • Managing project priorities and timelines Skills/Knowledge Required: • BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years experience • Advanced knowledge of clinical database design is a must (Inform, Oracle Clinical or other systems). • Experience managing clinical programmers • Participation in at least one NDA is preferred • Good communication skills; ability to work in a team environment with data manag ers, medical personnel, clinical monitors, statisticians, programmers, and medical writers • Knowledge of FDA/ICH guidelines and industry standard practices regarding programming • Medical or mathematics/computer science background a plus • Detailed knowle dge and experience in case report form design, central laboratories, programming databases, query resolution, data validation • Knowledge of SQL and SAS programming • Computer skills: detailed knowledge of clinical database design (Oracle Clinical or Infor m), proficiency with SAS data sets and conversion procedures, knowledge of MS Office program suite • Knowledge of clinical trial de sign and basic statistics (a plus)
Senior Clinical Data Manager
Perform DM activities inhouse: protocol review, CRF development, database set up activities, data validation process (including manual data review of listings), SAE reconciliation, managing local laboratory and external labs and database lock.
Perform Project Management : represent DM on clinical teams, coordinate deliverables by other functions and/or CRO as necessary to achieve DM deliverables.
Coordinate with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM,)
Coordinate CRO data validation activities (coordinate data transfer specs, data reconciliation, query generation and resolution,
Participate in the development and implementation of department standards and documents, and other data management, departmental activities as needed.
Minimum 5 years experience in Data Management with some experience in managing projects, project teams
Experience in handling local labs, external data
Experience in managing CRO, global team
Experience with In-Form or other EDC software is desirable however, should have some experience in supporting Oncology studies
Ideal candidate possesses above description, but also the ability to be independent, ability to sort critical issues that should be escalated to superior, and ability to propose sensible solutions.
Drug Safety Specialist:
The Drug Safety Specialist is: A regional role based at Berkeley Heights, NJ
reporting (at a minimum) to Manager, Case Management and is Responsible for:
Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately computerised
Note = For Contract positions functionality may be narrowly defined based on business needs
AE CASE MANAGEMENT
Receipt
Execute receipt of Drug Safety phone calls and complete telephone AE form
Create phone call communication logs in ARISg
Triage
Support the triage of cases conducted by Senior Specialist as needed
Assessment
Execute QC on key fields of serious cases
Create key fields updates in ARISg based on QC, as needed
Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)
Create narratives as needed
Review & update auto-narrative as needed
Create draft company comments for serious cases
Develop event rankings
Create dechallenge / rechallenge determinations
Develop follow-up needs for AE reports
Create targeted follow-up letters
Review and update generated follow-up letters as appropriate
Authorize (approve) non-serious cases
Create major modifications following Medical Review
Medical Review
Support the identification of corrections and creation of updates in ARISg following medical review
PHARMACOVIGILANCE (APPROVED PRODUCTS)
PSURs
Update AE reports within safety database to support line listings
COMPLIANCE, STANDARDS, TRAINING & PROJECT MANAGEMENT
Preparation for Regulatory Inspection
Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates
INTERNAL GLOBALSAFETY DEPARTMENT DEVELOPMENT
Participate in team meetings within the drug safety department
Contribute to the orientation and training of staff as needed.
The candidate must be able to produce a high volume of high quality cases within a busy Drug Safety work environment. Healthcare professionals are preferred.
Outsourcing Manager
Responsibilities will include, but are not limited to, the following: 1. Perform and manage all activities associated with the development and execution of contracts with Clinical Research Organizations performing clinical trial services and other vendors as necessary 2. Prepare study specific request for proposals (RFPs); manage and influence RFP process (vendor selection), competitive bidding negotiations, benchmarking and sourcing strategy 3. Prepare contracts, negotiate any requested changes to wording, identifying changes to the Legal department and coordinate any changes requested in areas of the contract that are critical to interest. 4. Track, manage and monitor all changes to study scope ensuring timely change order finalization and implem entation 5. Negotiate contract and change order costs of moderate to high complexity 6. Manage vendor relationships and issue resolution of moderate to high complexity 7. Monitor vendor performance in accordance with contract, utilizing metrics and benchmarking 8. Involved in projects or programs (complex and multiple) 9. Lead Medical Operations Initiatives 10. Responsible for making decisions & direction of outcomes 11. High organizational impact 12. Contribute to strategy and new processes, Identify new best practices & Contribute to continuous improvement 13. Anticipate & prevent problems & create backup plans 14. Requires minimal supervision, independently author contractual documents and design and revise templates as required 15. Able to lead others, provide direction to teams and coach lower level staff 16. Interact with internal and external customers 17. Capitalize on strengths of relationships/networks to effectively negotiate project contracts 18. Influence line functions and support the development and updating of department processes and tools 19. Member of cross-functional teams- may lead mtgs. as appropriate and influence line functions 20. Update tracking system with all contracts/cost information, and maintain an electronic library of previously negotiated contracts 21. Train & coach others in processes and industry practices 22. Maintain business intelligence through monitoring outsourcing environment & awareness of industry trends Skills/Knowledge Required: • Advanced knowledge of contract te rms and conditions ( T&C) • Advanced knowledge of benchmarking, market analyses and financial negotiations • Advanced problem solving skills in a team environment • Excellent negotiation or influencing skills • Proficient in drug development process • Comp etent in computer skills, oral & written communication & multi-tasking • Ability to manage personal timelines provide input to support staff timelines • Ability to establish and influence team timelines & expectations • Knowledge of GCP guidelines