Sr. Principal Statistics
GlobalchannelmanagementParamus, New Jersey
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.1
Reclaim your time by letting our AI handle the grunt work of job searching.
We continuously scan millions of openings to find your top matches.
Overview
Schedule
Full-time
Career level
Senior-level
Remote
On-site
Job Description
Sr. Principal Statistics needs 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience
Sr. Principal Statistics requires:
- SAS, ICH guidelines, CDISC data structures, FDA guidelines, SAP preparation, TFL shells, CRF review, database design review, edit check specifications, sample size calculation, analysis dataset validation, CRO oversight
- Education: 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
- Exceptional interpersonal skills and problem-solving capabilities
- Ability to work independently and collaboratively
- Ability to provide leadership for the CRO statisticians and statistical programmers
Sr. Principal Statistics duties:
- 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
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
FAQs About Sr. Principal Statistics Jobs at Globalchannelmanagement
What is the work location for this position at Globalchannelmanagement?
This job at Globalchannelmanagement is located in Paramus, New Jersey, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Globalchannelmanagement?
Employer has not shared pay details for this role.
What employment applies to this position at Globalchannelmanagement?
Globalchannelmanagement lists this role as a Full-time position.
What experience level is required for this role at Globalchannelmanagement?
Globalchannelmanagement is looking for a candidate with "Senior-level" experience level.
What is the process to apply for this position at Globalchannelmanagement?
You can apply for this role at Globalchannelmanagement either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.