| Job List |
| Job ID: |
CLM-01078-1 - Associate Director/Director Biostatistics |
| Description: |
JOB STATEMENT: The primary focus of this position is to analyze, interpret and summarize safety and efficacy data associated with Phase 1, 2, 3 and 4 clinical trials for multiple new drug and biological products, as well as medical devices.
ESSENTIAL JOB FUNCTIONS:
Consult with Sponsor clientele on clinical study design, statistical analysis plans and interpretation of results
Co-develop protocols, especially statistical considerations section, e.g., sample size calculation
Mentor junior statisticians in the writing of analysis plans, statistical reports and program specifications
Stay current in the field by networking and making presentations
Allocate departmental resources to maximize utilization and increase profitability
JOB REQUIREMENTS / EDUCATION / EXPERIENCE:
Ph.D. in Biostatistics, preferably with one or more publications related to clinical research
5 to 10 years related experience in clinical trials in biopharmaceutical industry preferred
Excellent interpersonal, verbal and written communication skills a pre-requisite for advancement
Proficient with SAS and other statistical programming languages, e.g., S-PLUS
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 5-10 Yrs,
Start Date: ASAP,
Location: Atlanta. GA |
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| Job ID: |
CLM-02018-2 - Associate Director/Director Biostatistics |
| Description: |
JOB STATEMENT: The primary focus of this position is to analyze, interpret and summarize safety and efficacy data associated with Phase 1, 2, 3 and 4 clinical trials for multiple new drug and biological products, as well as medical devices.
ESSENTIAL JOB FUNCTIONS:
Consult with Sponsor clientele on clinical study design, statistical analysis plans and interpretation of results
Co-develop protocols, especially statistical considerations section, e.g., sample size calculation
Mentor junior statisticians in the writing of analysis plans, statistical reports and program specifications
Stay current in the field by networking and making presentations
Allocate departmental resources to maximize utilization and increase profitability
JOB REQUIREMENTS / EDUCATION / EXPERIENCE:
Ph.D. in Biostatistics, preferably with one or more publications related to clinical research
5 to 10 years related experience in clinical trials in biopharmaceutical industry preferred
Excellent interpersonal, verbal and written communication skills a pre-requisite for advancement
Proficient with SAS and other statistical programming languages, e.g., S-PLUS
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 5-10 Yrs,
Start Date: ASAP,
Location: San Jose, CA |
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| Job ID: |
CLM-01248-1 - Clinical Data Associates |
| Description: |
Purpose of Position:
The primary focus of this position is on the management of clinical trial data, initiating with study start up phase activities, continuing with the conduct phase activities through to database lock and freeze phases.
Requirements and Responsibilities:
Conformance to company's policies and procedures is essential
Work with a multi-disciplinary team to ensure efficient design of case report forms, data validation specifications, discrepancy management and data processing
Assume direct responsibility for the final data quality
Customize implementation on a client by client basis
Education & Experience:
Conformance to company's policies and procedures is essential
Oracle Clinical experience, RDC experience beneficial
Bachelors degree desired, with a minimum of three years direct clinical data management experience with Phase III clinical trial data
Preference given to candidates who have demonstrated successful implementation of multiple studies conducted in several medical indications through experience of data validation specification writing, case report design and discrepancy management.
Computer skills including basic Microsoft Office applications
Strong problem skills
Confidence, initiative and strong communication skills
Thorough knowledge of medical and pharmaceutical industry, terminology and practices.
Travel:
Minimal if required.
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 3+ Yrs,
Start Date: ASAP,
Location: San Diego, CA & Mississauga, ON |
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| Job ID: |
PS-07076-7 - Director, Biostatistics (CNS) (EGC) |
| Description: |
* Technical expertise and demonstrated capability in leading statistics teams within the pharmaceutical industry
* Expertise may be technically rather than managerially focused
* Establishing reputation within the pharmaceutical biostatistics field
* Experience in assisting in compound submissions together with broad understanding and experience of the clinical development process
* Directs the biostatistics strategy and contributes to its outcome within area of responsibility
* Assumes accountability for analysis for clinical trials/clinical development plans across EGC multiple therapeutic areas and worldwide locations, potentially having primary site responsibility
* Begins to take an enterprise-wide perspective and influence the proper use of statistics throughout EGC
* Interacts with external stakeholders through daily work
* Contributes to innovation within the biostatistics field and an active member of societies and institutions
Qualifications
* Minimum of a Masters degree in Biostatistics or related discipline. MD or PHD highly preferred
* At least 10 years relevant experience in the pharmaceutical industry, including line management experience |
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Salary: Open,
Job Type: Permanent,
Total Exp: 10+ Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
DS-01108-6 - Director, Clinical Data Management |
| Description: |
Located in central NJ, this is a biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The Company has utilized the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development.
Their goal is to become a fully-integrated biopharmaceutical company that has the capability and resources to take its novel pipeline compounds and develop them from the research and development stage through to commercial manufacture, marketing and sales. With their first innovative cancer drug on the market and late stage clinical candidates soon to be, they have cooperative agreements with several big pharmaceutical companies to help market their drugs. A solid, fast growing midsized company which incorporates the best of both worlds, security with room to grow.
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Salary: 140-160k,
Job Type: Permanent,
Total Exp: 5 Yrs,
Start Date: ASAP,
Location: Branchberg, NJ |
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| Job ID: |
CLM-01078-2 - Manager Biostatistics |
| Description: |
JOB STATEMENT: The primary focus of this position is to analyze, interpret and summarize safety and efficacy data associated with Phase 1, 2, 3 and 4 clinical trials for multiple new drug and biological products, as well as medical devices.
ESSENTIAL JOB FUNCTIONS:
Consult with Sponsor clientele on clinical study design, statistical analysis plans and interpretation of results
Co-develop protocols, especially statistical considerations section, e.g., sample size calculation
Mentor junior statisticians in the writing of analysis plans, statistical reports and program specifications
Stay current in the field by networking and making presentations
Allocate departmental resources to maximize utilization and increase profitability
JOB REQUIREMENTS / EDUCATION / EXPERIENCE:
Ph.D. in Biostatistics, preferably with one or more publications related to clinical research
5 to 10 years related experience in clinical trials in biopharmaceutical industry preferred
Excellent interpersonal, verbal and written communication skills a pre-requisite for advancement
Proficient with SAS and other statistical programming languages, e.g., S-PLUS
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 5-10 Yrs,
Start Date: ASAP,
Location: Atlanta. GA |
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| Job ID: |
CLM-01248-2 - Manager, Clinical Data Associates |
| Description: |
JOB STATEMENT: The primary focus of this position is on the management of Clinical Data Associates and the management of clinical trial data from the design of the case report form through the initiation of the final reporting process.
ESSENTIAL JOB FUNCTIONS:
Responsible for management of Clinical Data Associates
Provide training to Clinical Data Associates for study related activities
Provide input to management team regarding Clinical Data Associate activities
Act as Lead Clinical Data Associate for small to medium clinical trials (Phase I and II)
o Draft or supervise the creation of study startup documentation
o Attend study management team meetings (internal and with client)
o Act as primary contact for study team for data cleaning activities through database lock and freeze
Assume direct responsibility for the final data quality
Assist in the 1st and 2nd pass data entry of clinical data
Regular client interaction, including limited travel
Strict adherence to Clinimetrics policies and procedures
JOB REQUIREMENTS / EDUCATION / EXPERIENCE:
BS/BA degree required, with preference given to those in the scientific or analytical fields
Strong interpersonal and communication skills
Ability to achieve results through innovation and initiative
Strong problem solving skills
Proven leadership and project management skills
Thorough knowledge of medical and pharmaceutical industry, terminology, and practices
Minimum 5 years direct data management experience with Phase III clinical trial data using a standard Clinical Trials database, experience with Oracle Clinical software preferred
Demonstrated experience in the implementation of multiple studies conducted in several medical indications
Knowledge of Adverse Event and Concomitant Medication data and the mapping to thesaurus terms helpful
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 5+ Yrs,
Start Date: ASAP,
Location: Atlanta, GA |
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| Job ID: |
CLM-09287-1 - Manager, Clinical Data Management Operations |
| Description: |
Core Responsibilities
Work with the Project Manager (PM) and CDM SMT members to establish and adhere to timelines for all CDM activities for assigned projects.
Take responsibility for the projects CDM budgets. Work with the PM and CDM SMT members on proactive management of study budgets.
Ensure Study Management Team (SMT) members in CDM understand study budgets, scope of work, timelines, and deliverables throughout the studies.
Work with the PM and CDM SMT members to ensure quality is built into the deliverables.
Direct and monitor the CDM tasks according to budget and timelines. Proactively identify, communicate, and recommend resolution of budget, resource, schedule, and quality issues.
Prepare input to change orders and communicate out of scope activities to Business Development (BD), PM and the Client.
Act as a CDM advocate to non-CDM groups by facilitating inter-group discussions and supporting CDM SMT members.
Participate in cross-group, cross-client discussions and prioritizations with CDM line management.
Attend and actively participate in necessary project, office, and company meetings related to assigned studies.
Attend BD capabilities, live RDC demonstrations and proposal defense meetings.
Serve as the CDM expert on SMTs and in potential new business situations.
Experience and Education Requirements
BA/BS degree.
A minimum of 5 years of pharmaceutical and/or CRO Clinical Data Management, 7 years of business management, or equivalent combinations.
Budget management experience.
Excellent analytical, problem solving, negotiation, interpersonal and verbal/written communication skills are essential.
Strong presentation skills are desired.
Requires strong project management skills and experience in managing multiple complex projects.
Proficiency in Microsoft Office for Windows including Word, Excel, and PowerPoint.
Microsoft Project experience highly desirable.
Working Conditions
Repetitive computer usage (5-6 hours per day)
Some travel required
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 5+ Yrs,
Start Date: ASAP,
Location: Atlanta, San Jose, San Diego, Mississauga, On. |
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| Job ID: |
PC-11157-5 - Principal Biostatistician |
| Description: |
Job Description:
Work with scientists in Drug Safety Evaluation, Pharmaceutical Development, andDrug Discovery. Ensure that appropriate statistical techniques are used which guarantee the scientific validity and overall quality of results. Assist in thedesign, validation and maintenance of SAS programs for the analysis of carcinogenicity studies. Provide instruction and seminars on statistical methodology.
Education Requirements:
Ph.D. degree in Statistics, Biostatistics.
Experience Requirements:
At least 5 years of experience as a biostatistician in the pharmaceutical industry or a medical research environment. Programming expertise with knowledge of SAS Statistical Analysis System required. Development of leadership skills so as to coordinate lead members of a R&D project team. Expanding knowledge of regulatory requirements and their impact on development programs. Increased interactions with regulatory agencies and statistical clinical consultants. Increasing scope and quality of influence as an effective member of a project team. Enhancing expertise in the development of protocols, statistical analysis plans and study reports.
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Salary: 110-110K,
Job Type: Permanent,
Total Exp: 5 Yrs,
Location: Hopewell, NJ or Wallingford, MA |
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| Job ID: |
PC-11157-3 - SAS Principal Analyst II |
| Description: |
Job Description:
Contribute to computer programming efforts for a clinical trial drug project and to provide programming support for clinical trial data reporting and regulatory submissions. Assumes protocol level and some project management responsibilitywhile supporting the Programming and Statistics lead. Able to support multiple protocols independently and to contribute to integrated summaries of efficacy and safety. Demonstrates strong SAS programming skills participates in protocol team and some project team interactions. Builds successful relationships and seamless interfaces at the protocol project team level. Provides timely and effective communication to the programming and statistics leads.
Education Requirements:
MS/MA is required
Experience Requirements:
Experience in SAS programming related to clinical drug development. Familiarity with data management principles and exposure to requirements for statistical computation regarding layout and presentation of data to support programming analyses. Significant academic training in computing, statistics, or other scientific discipline MS/MA or equivalent experience required at least 4 years relevant experience in the pharmaceutical industry
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Salary: 90-95k,
Job Type: Permanent,
Total Exp: 4,
Location: Hopewell, NJ |
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| Job ID: |
PC-11157-4 - SAS Principal Analyst II |
| Description: |
Job Description:
Contribute to computer programming efforts for a clinical trial drug project and to provide programming support for clinical trial data reporting and regulatory submissions. Assumes protocol level and some project management responsibilitywhile supporting the Programming and Statistics lead. Able to support multiple protocols independently and to contribute to integrated summaries of efficacy and safety. Demonstrates strong SAS programming skills participates in protocol team and some project team interactions. Builds successful relationships and seamless interfaces at the protocol project team level. Provides timely and effective communication to the programming and statistics leads.
Education Requirements:
MS/MA is required
Experience Requirements:
Experience in SAS programming related to clinical drug development. Familiarity with data management principles and exposure to requirements for statistical computation regarding layout and presentation of data to support programming analyses. Significant academic training in computing, statistics, or other scientific discipline MS/MA or equivalent experience required at least 4 years relevant experience in the pharmaceutical industry
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Salary: 90-95k,
Job Type: Permanent,
Total Exp: 4,
Location: Wallingford, CT |
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| Job ID: |
CLM-02018-1 - SAS Senior Statistical Programmer/Analyst |
| Description: |
JOB STATEMENT: The primary focus of this position is to perform and lead statistical programming tasks associated with Phase 1, 2, 3 and 4 clinical trials for new drug and biological products, as well as medical devices.
ESSENTIAL JOB FUNCTIONS:
Develop policies and procedures.
Provide leadership and work on multiple clinical projects
Train/mentor statistical programmers.
Successful completion of programming tasks on time and on budget
Expected to provide leadership in new technologies and procedures for improved efficiencies.
Design, develop and test SAS software to implement Program Analysis Specifications (PAS) for multiple projects.
Document and validate SAS software development according to Biostatistics standard operating procedures.
JOB REQUIREMENTS / EDUCATION / EXPERIENCE:
Bachelor or Masters degree in a scientific discipline, preferably Statistics or Computer/Health Science.
Minimum of three to five years Statistical Programmer Analyst III experience relevant biopharmaceutical industry experience.
Ability to train/mentor statistical programming support staff.
Knowledgeable about regulatory and ICH Guidelines as it pertains to project support.
Excellence in interpersonal, verbal and written communication skills a pre-requisite for advancement.
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Salary: Open,
Job Type: Permanent,
Total Exp: 3-5 Yrs,
Start Date: ASAP,
Location: San Diego & Mississuaga, ON |
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| Job ID: |
PC-11157-1 - SAS Technical Manager |
| Description: |
Job Title: Technical Manager
Location: Hopewell, NJ and Wallingford, CT
Job Description:
Responsible for the development and implementation efforts for the globalization, improvement, and standardization of processes and systems that support clinical trial data reporting and regulatory submissions. Contributes to theproject leadership of an indication for a late stage development program. Demonstrates advanced SAS programming skills evaluates processes in order to increase efficiencies and develop innovative strategies and technologies for flexible and global clinical trial reporting. Negotiates within the department and cross functionally, building successful partnerships and seamless interfaces. Provides timely and effective communication to team members, highlighting GBS goals and priorities, ensuring work efforts parallel departmental objectives. Supports teams by providing technical direction, coaching and feedback to programmers. Provides input into the development and technical training needs of programmers. Familiarity withdata management principles and exposure to requirements for statistical computation regarding layout and presentation of data to support programming analyses.
Education Requirements:
MS/MA is required
Experience Requirements:
Significant academic training in computing, statistics, or other scientific discipline MS/MA is required and at least 6 years SAS programming experience in the pharmaceutical industry and some experience supervising technical resources.
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Salary: 100-110k,
Job Type: Permanent,
Total Exp: 6,
Location: Wallingford, CT |
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| Job ID: |
PC-11157-2 - SAS Technical Manager |
| Description: |
Job Title: Technical Manager
Location: Hopewell, NJ and Wallingford, CT
Job Description:
Responsible for the development and implementation efforts for the globalization, improvement, and standardization of processes and systems that support clinical trial data reporting and regulatory submissions. Contributes to theproject leadership of an indication for a late stage development program. Demonstrates advanced SAS programming skills evaluates processes in order to increase efficiencies and develop innovative strategies and technologies for flexible and global clinical trial reporting. Negotiates within the department and cross functionally, building successful partnerships and seamless interfaces. Provides timely and effective communication to team members, highlighting GBS goals and priorities, ensuring work efforts parallel departmental objectives. Supports teams by providing technical direction, coaching and feedback to programmers. Provides input into the development and technical training needs of programmers. Familiarity withdata management principles and exposure to requirements for statistical computation regarding layout and presentation of data to support programming analyses.
Education Requirements:
MS/MA is required
Experience Requirements:
Significant academic training in computing, statistics, or other scientific discipline MS/MA is required and at least 6 years SAS programming experience in the pharmaceutical industry and some experience supervising technical resources.
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Salary: 100-110k,
Job Type: Permanent,
Total Exp: 6,
Location: Hopewell, NJ |
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