• 1) Lead the development of the Data Quality Management Plan, define edit checks, perform autoencoding, and extract data from SAS databases. Adhere to corporate Worldwide Safety Standards (WSS) and departmental SOPs for all clinical database management functions. Document all efforts in the cleansing, releasing and quality control of the database;
• 2) Provide clinical database management expertise based upon therapeutic knowledge and experience. Assume an active role in the review of the case report forms (CRFs). Communicate data processing issues and data inconsistencies to the DMT/GDT as well as members of the CDO Team and provide suggestions for resolution;
• 3) Maintain and execute computer programs for the evaluation and validation of incoming clinical data. Generate queries as a result of executing the computer programs and obtain appropriate resolution to each query;
• 4) Interface and provide support to Contract Research Organizations on all clinical database management activities. Interact with the Biometrics Operations Support (BOS) group for database creation and database capture administration; &
• 5) Reports to the Manager Clinical Data Management.

EDUCATION: Bachelor's degree or equivalent in a natural science.

• 1) Coordinate all activities that apply to building a project database, in Oracle Clinical, which adhere to standards and facilitate data collection, cleaning, and statistical analysis;
• 2) Collaborate with the BOS Graphics Design group on CRF development to ensure that corporate Worldwide Safety Standards (WSS) and standard efficacy CRF pages are consistent with Oracle Clinical database and metadata structures;
• 3) Establish project databases that adhere to WSS and departmental efficacy standards;
• 4) Request metadata to support database development from the CCRS Global Librarian, under the direction of the Manager Database Development and Administration;
• 5) Assure that databases, edit checks and associated SAS extract views, where applicable, are established prior to receipt of study data (testing and documenting derivation and validation procedures and coordinating with other BOS personnel or StAR team members to supply PL-SQL or SAS code when necessary);
• 6) Register protocol and related information by entering protocol, investigator and site identifiers into Oracle Clinical;
• 7) Create and maintains data entry screens in Oracle Clinical;
• 8) Perform randomization activities within Oracle Clinical.

• 1) Process clinical data required for analysis of clinical trials for marketed products, or for the production of safety reports (including projects, for which the Department has been requested to provide programming support);
• 2) Interact with members of GDT and DMT product teams, statisticians and data managers to establish project timelines, computerized data validation checks and statistical analyses (safety and efficacy); &
• 3) Develop computer software necessary for preparing, processing and analyzing clinical data. Investigate new methodologies and statistical techniques for the computer processing and statistical analysis of clinical data.

• 1) Participate in the strategic planning of U.S. and International phase IIIB - IV clinical trials in support of in-line products;
• 2) Assume responsibility for the conduct, analysis and reporting of individual clinical studies and meta analysis of clinical information;
• 3) Collaborate with clinical, marketing, regulatory and data Management colleagues to support the corporate initiatives to optimize the use of cumulative clinical information;
• 4) Expand product development opportunities in the new health care delivery environment in association with experts in clinical research, outcomes research, and pharmcoeconomics;
• 5) Communicate with colleagues in Central Research to share knowledge and data on pipe-line products.

• Develop project analysis plan, including computer-generated table specifications, statistical analysis plan, and research report format.
• Verify statistical programs, statistical results, and data sets used in statistical section of technical documents.
• Write statistical section of technical documents, including protocols when requested.
• Specify statistical terms and procedures and define equations for derived variables.
• Prepare project summaries for weekly/monthly status meetings.
• Maintain project notebook (including correspondence records).
• Maintain client contact, under the direction of the Director, Technical Analysis, according to schedule or as deemed necessary.
• Provide final quality assurance check of research report.
• Update knowledge in statistical concepts, methods, and techniques, and maintain state of the art statistical applications in clinical research.

II. External: Occasional Contact with Client Project Contacts.

II. Experience: Previous experience with the design and analysis of clinical trials is highly preferred.

• Develop project analysis plan, including computer-generated table specifications, statistical analysis plan, and research report format.
• Verify statistical programs, statistical results, and data sets used in statistical section of technical documents.
• Write statistical section of technical documents, including protocols when requested.
• Specify statistical terms and procedures and define equations for derived variables.
• Prepare project summaries for weekly/monthly status meetings.
• Maintain project notebook (including correspondence records).
• Maintain client contact, under the direction of the Director, Technical Analysis, according to schedule or as deemed necessary.
• Provide final quality assurance check of research report.
• Update knowledge in statistical concepts, methods, and techniques, and maintain state of the art statistical applications in clinical research.

II. External: Occasional Contact with Client Project Contacts.

II. Experience: 5 years previous experience with the design and analysis of clinical trials is required.

• Implement standard and custom data listing, summary programs, graphs, and statistical figures for inclusion in NDAs.
• Assist in developing report table specifications.
• Validation of programs developed.
• Assimilate database structures.
• Contribute to project documentation.
• Develop standard programming procedures.
• Maintain quality assurance.
• Support programming needs within company.

II. External: Technical and project staff at client sites.

II. Experience: At least 5 years of programming experience. Extensive knowledge of SAS and knowledge of C, C++, Pascal, or other high-level 3rd or 4th generation languages is preferable. Previous experience in troubleshooting and team development is required, as well as the ability to adhere to standards. Exposure to the pharmaceutical industry is required.

• Implement standard and custom data listing, summary programs, graphs, and statistical figures for inclusion in NDAs.
• Assist in developing report table specifications.
• Validation of programs developed.
• Assimilate database structures.
• Contribute to project documentation.
• Develop standard programming procedures.
• Maintain quality assurance.
• Support programming needs within company.

II. External: Technical and project staff at client sites.

II. Experience: At least two years of programming experience. Extensive knowledge of SAS and knowledge of C, C++, Pascal, or other high-level 3rd or 4th generation languages is preferable. Previous experience in troubleshooting and team development is required, as well as the ability to adhere to standards. Exposure to the pharmaceutical industry is required.

• Advanced Statistical degree, preferably in applied statistics.
• At least 5 years of statistical / business experience, preferably in direct or target marketing. This must include, but is not limited to, business experience using regression, logit, CHAID, clustering. Neural Nets or any other newer techniques a plus.
• Recognized leadership qualities.
• Exhibits pattern of experimentation and research into new statistical techniques.
• Highly skilled in problem solving / trouble shooting techniques.
• High level of statistical / business fluency in order to provide consultative services within the department and the company as well as to clients.
• Articulate, with an ability to explain complex statistical/analytic concepts to someone without the statistical background.
• Ability to take the lead in the introduction of new techniques and analytic services.
• SAS proficiency.
• Mainframe experience - (not just SAS on the PC).
• Ability to work with little or no supervision.
• Ability to work with large datasets.

• Analyzes, reports and interprets results of various marketing and offer strategies. Determines profitability of these programs and strategies.
• Tracks performance of members to identify sales trends and marketing opportunities; segments current member database to allow for more targeted promotions.
• Develops sales promotion strategies designed to improve Video/DVD Club profitability by stimulating incremental sales, improving segmentation (repertoire, offer, etc.) and extending member life span.
• Designs statistically valid marketing tests, supervises test implementation and analyzes as well as interprets results from testing. Provides recommendations about marketing strategies based on analyses.
• Works with Sales Promotion, MIS and operational departments to ensure accurate implementation of marketing strategies and policies; must function autonomously establishing productive relationships with other marketing analytical and operational departments.
• Manipulates large data files using SAS to produce useful and relevant analyses.
• Enhances technical and analytical methods to improve efficiency and ensure accuracy and usefulness of results.

• Minimum of 3 years of related strategic/database marketing analysis experience.
• Managerial experience preferred.
• Demonstrated quantitative and analytical skills with an attention to detail.
• Strong SAS programming skill (or related analytical software).
• Mainframe (MVS, JCL) experience helpful.
• Experience manipulating large data files.
• Knowledge of PC software and databases.
• Excellent oral and written communication skills; must be able to communicate with senior management, marketing, financial and systems departments.
• Ability to work on multiple projects and set priorities.
• MBA (or equivalent advanced degree).

• Position time allocation: 1/3 time will be spent in model production and review. 1/3 time spent on model R & D to expand and improve the model. 1/3 time spent on researching issues and variables associated with the model.
• Work with multidisciplinary teams to identify product enhancements
• Work closely with Product Manager to ensure analytical design/development is consistent with program strategy and positioning
• Extracting, merging and manipulation of data in order to investigate determinants of drug spend/trend
• Achieve understanding of the underlying factors of drug expenditure
• Interface with IT Development and other groups in the operational implementation

• Bachelors Degree required, advanced degree in Biostatistics, public health, or epidemiology strongly preferred.
• Strong understanding of database systems/language/platforms (i.e., SAS, terradata, SQL)
• Minimum of 3-5 years related experience in one of the following areas: pharmaceutical, outcomes research, disease management, managed care or health care consulting.
• Strong background in data management and analysis of large data sets
• Ability to manage and deliver multiple projects
• Strong experience with relational databases and spreadsheet analysis, e.g. MS Excel and MS Access

Job Description: Within a systems and network management group assist with the support and enhancement of a SAS-based performance data warehouse. This includes the development and implementation of reports for our intranet web site, integration of new application-specific metrics into the data warehouse, and normal day-to-day support.

All work is on the Unix platform in an environment that includes both HP as well as Sun equipment. The performance data warehouse itself is based on the IT Service Vision product from SAS Institute.

Technical Skills Requirements

Duration 3-6 months, possibly longer
Start Date Immediate
Salary/Rate $60 - $80/hour range. However, will consider candidates with more experience at higher per diem rates.

We seek a seasoned Database Analyst who will be responsible for the design, creation, maintenance, the updating of and linking various databases used by the Risk Rating Analytics Unit of Global Corporate Investment Bank Risk Architecture. Designing and creating uniform databases from multiple sources and different file formats.

Will perform data cleaning and timely updates of databases, based on availability of source data. Generate customized research files to support development of Debt Rating Models and other departmental activities. A key responsibility is to ensure that the database design and data quality meet the requirements of the Risk Rating Analytics Unit members. Manage databases used to track, approve and assign passwords to model users. Work with Operations and Technology on distributions and updates of models. Support the team of 6-7 quantitative and corporate finance analysts on a wide range of projects, including data and debt-rating model testing.

Qualifications:

• Manage CRO data management activities: coordinate the development of study data management plans and edit checks, including specifying variable parameters to ensure consistency between studies, oversee the status of query resolution during the progress of a study, and manage the transfer of interim and final database transfers from CROs.
• Verify data quality: develop data quality standards and SAS programs to assess clinical study data quality; check data quality of ongoing trials as well as execute data checks on final study data prior to database data lock.
• Support web-based clinical trials: specify variable parameters and edit specifications for trials which use web- based site data capture systems; perform pre-production system testing for each trial; monitor the system during a trial: if such a system is licensed by CVT, this position will be responsible for actually performing and/or managing the tasks of creating clinical trial electronic CRFs and electronic CRF edit checks, training, documentation, and validation. Other responsibilities will be to review and maintenance of SAS programs, which manage WHO-DD, COSTART, and MedDRA coding; review CRFs for content, layout, and appropriate consistency with previous forms.

Need three top-notch statisticians, having experience in major pharmaceutical companies, to capitalize on the expansion of a major R&D program. Requirements include the following:
• a.. Ph.D. in Statistics/Biostatistics
• b.. NDA experience with major pharmaceutical companies.
• c.. Minimum 4-5 years experience in drug industry
• d.. Good understanding of ICH guidelines and FDA/EMEA experience
• e.. Skillful project management and communication abilities
• f.. Pre-Clinical position: pre/non-clinical experience
• g.. Clinical position: clinical experience
• h.. Manager position: 7+ years clinical experience & some leadership experience

Responsibilities - Essential Job Functions:

Using protocols, case report forms, data tables and data listings and data figures as source documents to write and edit (using the ICH format where appropriate) the following types of documents:

Position Requirements:

Education/employment history: