TechD ata is looking for Talent Identification Specialist, Outcome Research Biostatistician, Marketing Consultant, Biostatistician (one can be telecommute), SAS Programmer (some can be remote), Clinical Trial Manager, (One is a director level) for our pharmaceutical clients in Central 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 consulting services.
Talent Identification Specialist
JOB SUMMARY:
The contract Talent Identification Specialist will assist the Human Resources department in developing the talent pipeline for all open positions . In this role you will be responsible for reviewing applicant’s resumes along with position qualifications to determine fit for the position and then submitting them for review. In addition, you will be utilize networking skills, online job posting campaigns, and other techniques to develop candidates to present for open positions.
ACCOUNTABILITIES:
Include key interactions or dependencies with other jobs, functional areas and/or external service providers
If this role includes people management, describe this in one of the accountabilities below
If this role includes financial responsibility (e.g. budget management, forecasting…etc.)
Accountabilities Importance %
1. Review all incoming resumes for qualifications and fit for open positions 35
2. o Collaborate with recruiting leads and hiring managers to identify areas of need and help create strategic staffing plans to meet the needs of the business.
35
3. Create talent identification strategies and sourcing campaigns, and then drive them forward 20
4. o Work with management and the recruiting team to develop new recruitment strategies and give feedback on what is and is not working.
10
The table above may not detail all specific job duties/responsibilities
Please list additional cross-functional interactions and/or dependencies not already shown above
Human Resources Leads
Hiring Managers within departments with vacancies
REQUIREMENTS:
Education: College degree
Experience (e.g. Jobs, supervisory, industry, international, etc…):
3+ years of sourcing experience in a pharmaceutical environment.
3+ years of sourcing experience within a search firm experience and/or experience sourcing “in-house” for a biopharmaceutical company.
Well-versed in sourcing techniques and able to generate pipeline for all levels of positions in a variety of creative ways.
Specialized knowledge, Licenses, etc.:
Knowledge of ATS systems a plus (SuccessFactors a plus)
Needs to be well versed in all aspects of biopharmaceutical firms (R&D through commercialization)
Other skills/attributes:
Demonstrated alignment with values and culture
Statistician for Outcome Research Position 1
Position Summary
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)
MS or Ph.D. in Statistics or related field Minimum 5-year experience in pharmaceutical research or equivalent
Statistician for Outcome Research Position 2 (Econometrician, Economic Modeler)
Working with team lead, the main Roles and Responsibilities are:
Develop, execute and maintain complex cost-effectiveness models (e.g., Markov model, discrete event simulation) and budget impact models
Conceptualize scenarios and derive input for economic modeling from qualitative and quantitative data sources, including literature review, post-hoc analysis of patient-level RCTs, mixed treatment comparison, forecasting and observational studies
Assume quality control in the model development and analytic work, develop proposal, study report, user manual, presentations and/or manuscript to effectively communicate the findings
Incorporate country-specific perspective into the global model to support local reimbursement
Skills Skills:
Good understanding of healthcare system and reimbursement requirements in key countries
Strong expertise in modeling software such as VBA in Excel and SAS which includes Proc SQL, SAS macros, tables/listings/graphs and SAS/STAT
Strong data management skills and demonstrated record of practical expertise in health economics and outcome research (modeling and observational research)
Knowledge of R, OpenBUGS, or other analytic packages is a plus
Ability to perform statistical, analytic and programming tasks with high efficiency and limited guidance
Ability to plan, organize, and work on multiple tasks simultaneously and in multidisciplinary teams.
Self-motivated with ability to meet deadlines
Education Advanced degree in statistics, econometrics, psychometrics, or related quantitative sciences plus >4 years of experiences in health economics and outcome research
Biostatistician
Scope of Work: Contract Statistician III
Services: Contract Statistician will provide statistical support to the paliperidone (oral and long-acting injectable) program. This will include statistical support for the ongoing paliperidone palmitate 3-month Phase 3 studies (PSY-3011 and PSY-3012). Study PSY-3012 will have database lock, topline, final tables/listing/graphs in 2Q2014 and 3Q2014. The CSR and submission-related activities to the FDA will take place in 4Q2014. There will also be a 4-month safety update in 1Q2015. Limited safety data from the ongoing PSY3011 study will also be included in the submission. Contract Statistician will provide other support to help respond to Health Authority requests from around the world.
Deliverables : Contract Statistician will work with review and comment on the Statistical Analysis Plan (SAP) for study PSY-3012. Contract Statistician will:
Review the Data Presentation Specification (DPS) for studies PSY-3011 and PSY3012.
After approval, work with programming to ensure that the outputs are programmed appropriately.
Write independent SAS codes to validate the final tables/listing/graph.
Obtain input from the Statistical Leader and Protocol Statistician.
Liaise with the programming group to provide safety outputs for studies PSY-3012 and PSY-3011.
From time to time, Contract Statistician will be called upon to provide statistical support to help respond to Health Authority Requests
Sr. Statistical/SAS Programmer (Some position can be telecommuting)
Main purpose of the job:
Identify statistical and programming needs and use standard and customized SAS programs and macros
Review and modify standard programs appropriately when needed
Import/export data from/to other data management systems or outside sources,e.g., CROs
Integrate data from different sources (e.g., SAS datasets from different CROs, CRF data and electronic laboratory data
Create analysis datasets from raw datasets
Assess data integrity and validity of data, including edit checks
Generate statistical analyses and end-of-text tables, figures and listings specified in a statistical analysis plan and in-text tables and figures as specified in the report template
Create, validate, document, maintain and archive programming specifications and programs
Validate standard programs and macros written by other programmers
Generate statistical analyses and accompanying tables, figures or listings on an ad hoc basis as requested by other members of the project team after consultation with supervisor.
Estimate statistical and programming time requirements for team time lines
Establish core corporate standard SAS analysis data set conventions
Establish and maintain corporate SAS MACRO library
Coordinate with outside vendors to define format specifications for data transfers
Understanding CDISC stucture for both CRF datasets (SDTM) and analysis datasets (ADAM)
Note: The pay rate listed is the “total” bill rate to be billed to be inclusive of all transactional burdens by the supplier.
Marketing Consultant
1. Support approval of materials thru CAC/MLR by interacting with internal and external stakeholders (agencies, functional areas)
2. Plan and execute previously approved brand projects in support for the launch
3. Support development of core campaign and disease state awareness
4. Support and oversight of insights generation – ad-boards, focus groups and market research both virtually and on-site
Clinical Trial Manager:
Duties:
The Clinical Trial Manager will support North America Medical Affairs by managing investigator-sponsored trial operations and ongoing quality improvements in the processing and review of ISTs. The CTM will liaise with field medical teams, medical strategy, legal, and other departments as needed to ensure investigator sponsored trial requirements are met or exceeded.
Key responsibilities include coordination of concept submissions to cross-functional committee review teams, forecast and tracking of study budgets and milestones, ensure timely distribution of Dear Investigator Letters, oversee that study progress is tracked and reported to the cross-functional team, ensure clinical trial databases are maintained, and actively participate in process improvement initiatives, taskforces, and committees within Clinical Operations.
Role Responsibilities:
1) Participate in the review and critique of investigator-sponsored trial protocols for compliance with company policy and alignment with corporate strategy.
2) Track the execution of the ISTs and budgets from approval decisions through execution of contract payments, and outcomes.
3) Critically evaluate budgets for proposed ISTs.
4) Maintain an accurate and current database on the status of all ISTs.
5) Participate in cross-functional teams and ensure working teams meet frequently to evaluate IST progress and provide feedback
6) Provide mentoring to Clinical Trial Associates in study management and conduct of clinical trials, as appropriate
7) Demonstrate functional knowledge of Good Clinical Practices, Corporate policies and standard operating procedures as well as knowledge of applicable external regulatory requirements and guidelines
Skills:
Minimum of 4 years industry experience in a multidisciplinary Clinical, Research and/or Clinical Operations environment (e.g. pharmaceutical industry, a CRO or academic institution)
2-3 yrs or equivalent cross-functional team experience in project and / or portfolio management Involvement in cross-functional clinical trial teams; demonstrated capabilities in supporting trial planning, initiation, executing, and reporting activities.
**Preferred candidates will have IST experience; Oncology, diabetes, cardiovascular experience preferred.
Professional Skills and Knowledge Requirements: Ability to manage multiple projects and work across functions in a matrix organization -Excellent organization and tracking skills. -Proven ability to work both independently and in a team setting, and to meet set goals by managing own timelines -Able to proactively identify and propose solutions to operational activities -Strong oral and written communication skills -Strong and consistent attention to detail -Knowledge of Good Clinical Practice; solid knowledge of clinical trial design; understanding of the overall drug development process -Basic knowledge of principles for trial budgeting is preferable -Understanding of highly regulated pharmaceutical industry environment -Embodies vision, competencies, and values
Education:
Minimum of a BSN, BA or BS in a scientific discipline and at least 4 years of clinical research experience
Director, IST Operations-Clinical Trial Manager
Duties:
The Director of ISS Operations will strategically lead the scientific review process and all aspects of ISS management for Investigator Sponsored Studies (ISSs) to ensure optimum execution in accord with all internal standards and required external regulations and guidelines. The Director will ensure the success of the ISS program by being able to:
1) Apply principles of clinical research and an in depth understanding of clinical trial design, operational and feasibility assessments to ensure high value and a highly efficient ISS program;
2) Manage the activities pipeline and work with the Standards team to ensure that all ISS activities are audit-ready, conducted using the highest quality standards and are compliant with internal and external guidelines, policies and procedures.
3) Facilitate teamwork and work cross-functionally within a matrix organization to be effective and to ensure that all issues related to ISS trials are effectively communicated and understood across the company, including globally as appropriate;
4) Lead a team of clinical trial managers and clinical trial associates in the strategic planning, resourcing, management, and financial tracking for the ISS process to generate and communicate meaningful metrics and key performance indicators for ISS operations;
5) Champion innovation, ongoing quality analyses and continuous improvement.
Role Responsibilities Lead multidisciplinary groups and collaborate on ISS strategies to ensure that ISS Operations delivers on high priority studies/programs. Facilitate collaboration with medical, legal, finance, compliance, purchasing, field medical, global, etc. to ensure rigor and excellence in all aspects of strategy and execution. Modify current ISS procedures into highly efficient, streamlined processes ensuring transparency, consistency, customer-centricity, compliance, and rapid-response. Serve as voting member of the ISS grant review committees to provide feasibility assessment and to ensure operational compliance. Oversee the tracking and budgetary management for all ISSs. Maintain excellent cross-functional skills and approaches focused on balancing the needs and expectations of all stakeholders who interface with ISS grants and processing Build flexible organizational structure with effective deployment of resources Create and sustain relationships with direct reports, peers, and others based on mutual trust and integrity. Ensure the successful achievement of goals, operating within all policies, procedures, and corporate guidances In conjunction with other members of the Medical COE leadership team, advance the vision of the department and develop/support initiatives that impact the team.
Skills:
8-10 years in clinical research with solid foundation and expertise in clinical trial strategy, planning and design, and monitoring of study conduct. Firm knowledge of Phases I though IV Experience in Investigator Sponsored Trials is preferred Pharmaceutical Industry experience Management of direct reports Joint-venture relationship management Professional Skills: Proven ability as an effective leader (strategic thinking, decision making, problem solving, delegating, consensus-building, negotiating, etc) History of success in leading, managing, coaching and motivating people Managerial courage – ability to make difficult choices and implement successfully Understanding of highly regulated pharmaceutical industry environment and commitment to the applicable rules, regulations and requirements: GCP and ICH Standards, OIG, PhRMA, SOPs Staunch commitment to ethics and patient safety Proven interpersonal, communication (oral, written, editing) skills Excellent organizational skills Ability to work effectively in a rapidly evolving internal and external environment.
Education:
Bachelor’s Degree in science area with 8+ years pharmaceutical or biotechnology industry experience in clinical research, clinical operations or medical affairs;
Advanced degree preferred