Summary of Position: The Senior Manager in Statistics responsible for perform statistical ... Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues ...
62 Katalyst Senior Statistical Programmer Jobs Hiring Near You
Summary of Position: The Senior Manager in Statistics responsible for perform statistical ... Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues ...
The Senior Manager in Statistics responsible for perform statistical activities in clinical trials ... Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues ...
The Senior Manager in Statistics responsible for perform statistical activities in clinical trials ... Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues ...
Katalyst Jobs Information
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Katalyst appears to be a collaborative and innovative company that values creativity and teamwork, fostering an environment where employees can share ideas and work together to achieve common goals.
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Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
What makes Katalyst an attractive place to work?
Katalyst is a forward-thinking company that has established itself as a leader in its industry, known for its commitment to innovation and customer satisfaction. The company's work environment is characterized by a collaborative and dynamic atmosphere, where employees are encouraged to share ideas and work together to drive progress. Joining Katalyst offers opportunities for professional growth and development, as well as the chance to contribute to meaningful projects that can have a lasting impact.
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Full-time
Re-posted 25 days ago
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:
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
- 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 assigned
- Ph.D or MS in Statistics or Biostatistics
- 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
- Ability to work independently and problem-solve
- Ability to provide leadership for the CRO statisticians and statistical programmers
About Katalyst Healthcares & Life Sciences
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Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.
Industry
Scientific research and development services
Company size
51 - 200 Employees
Headquarters location
South Plainfield, NJ, US