Posted February 17, 2005
CLINICAL SAS OPPORTUNITIES:
Client # 1:
Northern California-FT
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-CT and FT
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 # 3: Northern
California
Our client in Northern California is looking for a SAS Programmer with MedDRA experience for a 6-month contract. The ideal candidate would have:
Client #4: Northern California-FT-Jr. SAS
Programmer
Our client in Northern California is looking for a Jr. SAS Programmer to assist and collaborate with the Senior SAS Programmers The minimum requirements for this position are:
Client #5:
Northern California-CT-SAS Programmer
Our client a leading biotech seeks a Senior Clinical SAS Programmer for a 6 month initial contract. You will be asked to perform SAS programming and development required for analysis of clinical trial data for a phase II and Phase III trail.
The responsibilities and scope of the job include:
· Program statistical analyses (i.e., tables, listings, figures, and inferential statistical output) using SAS.
· Perform SAS programming using techniques as SAS macro language, data manipulation techniques, and statistical procedures (e.g., PROC GLM, PROC FREQ, PROC REPORT).
· Act as an integral member of project team. Attend project team meetings; work with biostatisticians, data managers, and clinical research managers, as appropriate.
· Interact with technical and clinical staff in house, as required.
· Follow good programming practices and adequately document programs.
· Keep informed of SAS programming techniques as applied to clinical trials by reading relevant journals and/or attending courses/programming meetings.
· Be familiar with FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
In order to be considered you should have a degree combined with 4 years + of clinical SAS programming experience. Ideally strong statistics experience either through education or hands on statistical experience.
¨ 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
¨ Performing quality control for documents, programs and outputs of statistical programming.
In order to be considered for this job, you must have:
¨ Minimum experience with Ed or Ed/exp. combination equivalent to a post graduate degree in Computer Science, Life Sciences, Statistics or Statistics related field.
¨ Two (2) years pharm clinical experience w/bachelorıs degree or equiv.
¨ Working knowledge of medical terminology, clinical trial methodologies, and software systems development
¨ Working knowledge of at leas one scientific programming language and a t least one statistical software package (such as SAS, S Plus)
¨ Excellent analytical, problem solving and computer skills.
BIOSTATISTICIANS OPPORTUNITIES:
Client # 1: Biostatistician-Northern
California-FT-San Francisco/South San Francisco
Job Description:
Works with senior biostatistics
staff and clinical monitors on clinical development plans, the design and
conduct of clinical studies and in the evaluation, interpretation and
preparation of study results. As part of a clinical assessment team,
collaborates in the preparation and review of clinical assessments. For
assigned clinical development project(s), provides statistically sound
experimental design and data analysis input to meet project objectives and FDA
statistical requirements. Reviews all project protocols, author protocol
statistical analysis sections and generate study randomizations. Develops study
analysis plans as a team member; lead this effort for selected studies. Reviews
case report forms to ensure that protocol objectives are met and project
standards are maintained. Develops statistical programs as necessary to perform
analyses, prepare data displays, and verify data accuracy and validity. Authors
statistical analysis results in the clinical study report. With help from
senior statistical staff, leads team members to author the report.
Responsible for seeing the report through the review process. Supplies
statistical input for BLA submissions and in response to FDA questions.
Provides support for investigator publications. Keeps abreast of new
developments in statistics, drug development, and regulatory guidance through
literature review, workshop attendance, etc.
REQUIREMENTS: Experience with statistical software packages such as SAS
and S-Plus. Sound knowledge of theoretical and applied statistics. Sound
understanding of regulatory guidelines in a pharmaceutical research setting.
Effective communication skills. Effective team contributor.
EDUCATION: Ph.D. in statistics/biostatistics with at least 2 years of
clinical trials experience or a Master's Degree in statistics/biostatistics
with at least 5 years of clinical trials experience.
Client # 2: Biostatistician-( Northern California)-East
Bay-CT
Job description:
Provide statistical support to study
team. Write statistical methodology section of protocol and study report.
Experience with SAS so that can provide quality-control checking of SAS
programs and study deliverables such as tables, listings, and figures.
(Programming experience preferred.) Able to communicate clearly with programmer
and other study team members.
Requirements: Requires Masterıs degree in Statistics or
Biostatistics and at least 4 years of relevant
industry (Pharmaceutical or device)
experience. (3 years of relevant experience with a
Ph.D.)
Client# 3: Biostatistician-(
Southern California)-CT
Job Descriprion:
You will expand and broaden the scope of Biostatistics in
the area of pharmaceutical research; provide guidance in statistical analyses methodology;
and perform statistical programming, design and analyses for multiple clinical
trial projects. Direct and supervise project team members in all aspects of
design and statistical analyses and reporting on clinical research. Provide
consultation with clinical scientists, regarding the conduct of experiments,
clinical trials, statistical methodology and regulatory issues. Interact with
domestic and foreign regulatory agencies for R&D projects and programs in
the support of new product development, domestic and international regulatory
submissions and in the maintenance and growth of existing products.
Requirements:
Education and experience equivalent to a post graduate
degree in statistics or related field. 4 years of pharmaceutical experience with
a Ph.D. or equivalent. 7 years of pharmaceutical experience with a master's
degree or equivalent. 9 years of pharmaceutical experience with a bachelor's
degree or equivalent. Working knowledge of at least one statistical software
package (such as SAS, SPSS, BMDP, RS1) Excellent analytical, problem solving,
and computer skills. Flexible, well organized, and strong communication and
inter-personal skills. Works well under pressure, with initiative to take on
unfamiliar tasks.