Job Details:
 

Information about the position

Job Number:	1540
Job Title:	Clinical Programmer ( SAS and Oracle)
Date Posted:	7/8/2004

Job Description:

Bioinsource Inc. is an international consulting and staffing firm that specializes and prides in providing local and international talent to our clients in the biotech, pharmaceutical, diagnostic and medical device industries. With offices across the US and in Europe, we are able to provide you with extensive market knowledge, salary surveys and experienced career support when seeking a new permanent and/or contract position. Here is a list of our current job openings with different clients in the Bay Area as well as Southern California. Client # 1: Northern California SAS Programmer-Statistics Dept. REQUIREMENTS: Minimum of 4 years of SAS programming and 3 years of clinical trial experience. Advanced knowledge of the SAS programming language (especially data step, and summarization procedures), report generation, and standards for programming and validation. Experienced in macro writing. Knowledge of advanced statistics procedures is SAS including LIFETEST, MIXED, GLM. A working knowledge of basic statistics. Understanding of regulatory guidelines that affect statistical programming deliverables. Participation in a regulatory filing would be a plus. Experience with UNIX, or similar operating system. Ability to work on multiple tasks simultaneously and meet project deadlines. Good verbal and written communication skills. RESPONSIBILITIES: As a member of a clinical project team, the Senior Statistical Programmer Analyst plans, designs, develops, implements, and maintains software for the monitoring, reporting, and analysis of clinical trials. The Senior Analyst provides some leadership on technical or work projects. Develops and executes software to monitor ongoing studies, produce data listings, summary tables and graphics for interim and final analyses and publications. Reviews the CRF design, data management plans, and statistical analysis plans for impact on software systems and study analyses. Integrates data across studies within a project. Tests, documents, reviews and verifies all programs according to department Standard Operating Procedures. EDUCATION: B.S. in computer science, statistics, biology, or other relevant scientific area. Client #2: Northern California SAS Analysis Programmer Responsibilities: This position will be responsible for providing SAS programming in support of study analysis and data management activities. Description: • Design, program and validate analysis files, tables, listings and graphs. • Provide SAS programming support to data mangers for use in data cleanup and study tracking activities. • Provide SAS programming support for MD safety review of data • Participate in the development and validation of a new SAS programming environment Requirement: • At least two years SAS programming experience. • Excellent SAS skills including Base, Stat, Graph, and Macros. • Ability to contribute to a small interdisciplinary team, yet ability to work well independently. • Excellent spoken and written communication skills. Client #3: Northern California Statistical Programmer As a Statistical Programmer, you will be responsible for providing programming support for completion of Item 11 for electronic submission of drug candidate, validation of CRO’s analyses of front line results for two Phase 3 clinical trials, and development of processes and templates for the production of summary tables and data listings in a timely and efficient manner. The essential functions of the job are: • To process clinical data required for analysis of clinical trials for Phase 1-3 studies. Develop SAS coding and table templates for preparing, processing and analyzing clinical data in a timely manner consistent with SOPs and guidelines. • To provide programming support for validation of clinical trial databases. • Interact with members of in-house study teams, biometrics staff and CRO teams. • And, provide support for completion of Item 11 for use in e-submission. Job Qualifications: • Education: Bachelor’s degree or equivalent in statistics, biostatistics, mathematics or computer science is required. Master’s degree in statistics, biostatistics, or computer science preferred. • Experience: At least 5 years of relevant programming experiences in biotech or pharmaceutical industry, including experiences in multiple therapeutic areas and in various phases of drug development. • Skills: 1. Must have experience in supporting regulatory submissions. In particular, experience with electronic submissions and support of Item 11 is desired. 2. Must be able to work independently on multiple projects simultaneously. 3. Exceptional knowledge of the structure of clinical data and extensive experience in programming clinical data using SAS is required. 4. Extensive knowledge of SAS/Base, SAS/Macro, SAS/Graph, SAS/Stat and the ability to write maintainable, supportable and well-documented SAS code is essential. 5. Must possess excellent analytical and problem-solving skills. 6. Exceptional oral and written communication skills are a must. 7. Experience in Windows SAS is desirable. Client #4: Northern California Oracle Clinical Programmer Job Summary: Programs the relational database for statistical analysis and transfer of files to and from other databases to clinical protocols.  Responsible for the programming of the clinical trials department relational database including electronic data capture and outputting files for statistical analysis and transfer of files to and from other databases as appropriate to clinical protocols.  Develop data listings and other reports necessary for the management of clinical studies and for study reports.  Advises non-technical personnel on data retrieval and browsing of databases. 5 – 7 years experience developing applications with relational databases in the NT/Windows environment. Knowledge of FDA requirements regarding clinical data management documentation and software. Knowledge of Visual Basic, Oracle Clinical MS Access and SQL. RDE/RDC experience a plus. Client#5: Northern California SAS Clinical Programmer RESPONSIBILITIES: The Senior Clinical Programmer Analyst applies advanced level programming techniques and leadership to the design, development, implementation, and maintenance of software in support of monitoring, reporting, and analysis of clinical trial data quality. Uses creativity and ingenuity to solve complex problems (e.g. creates reusable code, develops project/ department standard code, designs interconnected programs). Works closely with clinical research professionals to identify project/study level needs (e.g. deliverables schedule, report approval process, standard reporting styles, etc.) and to create reports needed to identify/resolve data issues. Will be accountable for quality and timeliness of project deliverables, as well as their suitability to the intended task. Analyzes data capt Communicates effectively to coordinate problem resolution efforts with implementation team customers and functional peers. Contributes toward continuing process, business, and technical enhancements. Mentors junior staff. REQUIREMENTS: Minimum of 7 years of SAS programming or related experience with at least 4 years in pharma/biotech/health care industry. Strong understanding of clinical monitoring/data query process and proficiency in writing clear, concise SAS code for the purposes of data listing review. Intermediate UNIX, Oracle Clinical or equivalent clinical DM system, and relational database theory. Basic knowledge of regulatory environment and FDA/ICH guidelines e.g. 21 CFR Part 11. Conversant in good programming practice and the software development life cycle. Understands the functional areas of a clinical trial and their role throughout the study. Excellent communication skills essential: Candidate should be fully capable of clear and timely written and verbal communication with peers, customers, and management. EDUCATION: B.S. in relevant field or equivalent years of experience Client #6: Southern California Statistical Programmer Provides statistical programming support under the direction of senior staff for the creation, quality-control, documentation and maintenance of analysis data sets, tables, listings and graphs. Reviews CRF's and annotation, Database Lock Data Sets specifications and analysis plan. Assists in creating and maintaining analysis data set specifications. Designs, writes, debugs, tests, documents, maintains, updates statistical programs. Adopts and practices established programming standards, conventions, available Standard Reporting Systems and macro utility programs. Performs quality control for documents, programs and outputs of statistical programming. Requires education/exp combination equivalent to a post grad degree in Comp Sci, Life Sci, Statistics or Statistics-related field. With Bachelor's degree must have 2+ years pharm clinical exp. Less exp necessary with a Master's degree. Must have working knowledge of medical terminology, clinical trial methodology's, and software systems development. Working knowledge of at least one scientific programming language and at least one statistical software package such as SAS, SPlus Client #7 : Northern California Statistical Programmer Our client in the Bay Area is looking for a Statistical Programmer to work mostly on validation programming ( 70-80%) of the time for a PHASE 3 Clinical Study starting in JULY 2004. For a 6-month contract position. The ideal candidate must have: - M.S. or Ph.D. in Statistics or Applied Statistics is highly preferred - SAS programming skills of 3-5 years - At least 4-5 years in Statistical programming experience within a clinical trials environment - Excellent communication skills - Familiarity with medical/clinical terminology - Ability to take direction from project Statistician - Must be capable of reading and understanding the study protocol, Statistical Analysis Plan and documents on study structure - Must be experienced in various computer systems (UNIX), and PC-based computer networks - Must be proficient in SAS programming in Base, Macro, Stat, and Graph - Attention to detail and high standards for producing quality output

Platform:

Required Skills:

Desired Skills:

Duration:	CT/ Permanent
Start Date:	Immediately
Location:	Northern and Southern California
Travel:
Rate:

Information about the company

Company Name:	Bioinsource Inc.
Contact Person:	Todd Michaud
Contact E-Mail Address:	todd@bioinsource.com
Company Web Site:	www.bioinsource.com
Phone Number #1:	415-226-3350 ext.1
Phone Number #2:	415-226-3350 ext.2
Fax Number:	415-947-0866

Job Poster's Comments:

If interested, please forward your resume to one of our professional development experts and they will contact you to discuss these and other possible opportunities. Here at Bioinsource, we will work with you to obtain a position that is challenging and helps your career move in the right direction. Visit our website for more information about our company-www.bioinsource.com Contact: Bioinsource-SF Phone: 415-226-3350 Fax: 415-947-0866 West-coast opportunities: Todd Michaud-todd@bioinsource.com Paola Jaimes-paola@bioinsource.com