Job Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.
Job Title: Sr. Principal Statistics
Location: Paramus, NJ, 07652
Job Type: Temporary Assignment
Duration: 6 Months
Work Type: Onsite
Shift: 9.00AM-5.00PM
Shift: 9.00AM-5.00PM
Job Description:
Summary of Position:
- The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing.
Duties and Responsibilities:
- Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.
- Review CRF, database design, and edit check specs
- Review study quality surveillance plan and monitor study conduct
- Prepare and/or review SAP, TFL shells and specifications for variable derivation
- Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables
- Provide statistical and validation support for statistical analysis, analysis datasets and TFL Review study report, manuscripts and other documents related to statistics.
- Review study report, manuscripts and other documents related to statistic
- Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents
- Perform other ad-hoc statistical activities as needed
- Works effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming
- Participates in monitoring CRO activities and reviewing CRO deliverables
- Other duties as assigne
Qualifications:
Education Preferred:
- Ph.D or MS in Statistics or Biostatistics
Work Experience:
- Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience Excellent knowledge of SAS computer package
- Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines
- Excellent organizational skills, time management, and ability to meet established deadlines.
- Excellent communication and interpersonal skills to effectively interface with others Exceptional interpersonal skills and problem-solving capabilities
- Ability to work independently and collaboratively
- Ability to provide leadership for the CRO statisticians and statistical programmers
Physical and Mental Requirements:
- Ability to multitask
- Adapts to change
- Maintain composure under pressure
- Ability to follow verbal or written instructions and use of effective verbal communications
- Adapts change, adjust change and grasps information quickly
- Examine and observe details
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Paramus, NJ |
| Industry | Computer/IT Services |
| Salary | $85–$90 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
- Analysis Skillsunmatched
- Biotech and Pharmaceuticalunmatched
- Case Report Form (CRF)unmatched
- Clinical Data Interchange Standards Consortium (CDISC)unmatched
- Clinical Data Managementunmatched
- Clinical Practices/Protocolsunmatched
- Communication Skillsunmatched
- Contract Research Organization (CRO)unmatched
- Cross-Functionalunmatched
- Data Qualityunmatched
- Data Setsunmatched
- Data Structuresunmatched
- Database Designunmatched
- Diversityunmatched
- FDA (Food and Drug Administration)unmatched
- ICH Regulationsunmatched
- Identify Issuesunmatched
- Industry Standardsunmatched
- Interpersonal Skillsunmatched
- Leadershipunmatched
- Licensingunmatched
- Marketingunmatched
- Organizational Skillsunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Regulationsunmatched
- Regulatory Submissionsunmatched
- SAPunmatched
- Statistical Programming Languagesunmatched
- Statisticsunmatched
- Surveillanceunmatched
- Time Managementunmatched
- Workforce Managementunmatched
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