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Entries tagged with “components” from BiotechPharmJobs.com

Radiant Info Systems: Staff Analyst Statistical Programming, Cambridge, MA

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Radiant Info Systems


Job Description:

Job Title: Staff Analyst - Statistical Programming
Location: Cambridge, MA
Company: Radiant Info Systems
Contract: Duration: 6 months

Radiant Info Systems is looking for a Staff Analyst - Statistical Programming for its Cambridge, MA office.

Responsibilities:

• Supports statistical programming activities in the production of the analysis datasets, tables, listings, figures, electronic submission components, and complex ad hoc analyses
• Monitors and meets assigned study and program milestones and requests resources as needed
• Leads a small team of support statistical programmers to accomplish tasks and communicate issues to senior management as necessary
• Provides input to policy, operations, and capability building in Statistical Programming and Operations
• Leads cross-functional teams to implement policy, operations, and capability initiatives
• Develops and implements standard programming practices while also ensuring that they are employed across studies and programs
• Mentors less experienced programmers

Requirements:

• 5-10 years SAS Base programming, with 5-7 years using SAS STAT, GRAPH and MACRO
• 5-10 years relevant industry experience
• 5-10 years clinical trial experience
• At least 2 years clinical database experience
• Excellent knowledge of drug development process
• Knowledge of drug submission requirements

Education:

• Must have a Bachelor's degree or equivalent, preferably in a scientific discipline (i.e. Statistics, Mathematics, Economics, Computer Science, IT, Biology, Life Science)

To apply, please send your MS Word resume along with salary requirements to:
SPalakurthi@radiants.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Radiant Info Systems: Statistical Submissions Management Senior Analyst III, Cambridge, MA

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Radiant Info Systems


Job Description:

Job Title: Statistical Submissions Management Senior Analyst III
Location: Cambridge, MA
Company: Radiant Info Systems
Contract: Duration: 12 months

Radiant Info Systems is looking for a Statistical Submissions Management Senior Analyst III for its Cambridge, MA office.

Responsibilities:

• Coordinating, preparing, reviewing and managing Biostatistics electronic submission ready components for complex regulatory submissions
• Monitoring and meeting assigned project milestones and requesting resources while providing adequate submission status tracking reports, as well as metrics reports, to communicate progress and trends of electronic submission activities (i.e. submissions plans)
• Developing or implementing standard electronic submission practices and standards, while also ensuring that they are employed across studies and drug programs
• Providing submission support to complex ad-hoc and response requests from regulatory agencies

Requirements:

• Able to handle a large volume of highly complex tasks and work effectively under pressure and tight deadlines
• Able to use SAS programming software intensively and to review SAS programs and prepare the submission components
• Must have experience with clinical trial data and software used for electronic submissions purposes
• Must have great general computer proficiency, including Microsoft Suite applications
• Must have 5-10 years Adobe Acrobat and electronic submission applications experience utilized for electronic submission purposes
• Must have 5-10 years SAS experience with some demonstrated programming language experience
• Must have 5-10 years relevant experience in the pharmaceutical, biotechnology industry or CRO
• Must have a demonstrated ability in supporting project teams and management
• Must have extensive knowledge and application of applicable industry principles, concepts, techniques, and standards
• Must have full knowledge of applicable regulations and industry practices and ability to utilize the knowledge in the practice
• Must have excellent application of concepts and principles of electronic submission and drug development process

Education:

• Must have a Bachelor's degree or equivalent, preferably in a scientific discipline (i.e. Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.)

To apply, please send your MS Word resume along with salary requirements to:
SPalakurthi@radiants.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.
 

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