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Sr. Principal Statistics at head-huntress.com
Paramus, New Jersey, United States -
Full Time

Start Date

Immediate

Expiry Date

23 Aug, 26

Salary

0.0

Posted On

25 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Statistical Analysis, Clinical Trial Design, Sample Size Calculation, SAP Preparation, TFL Specifications, Regulatory Filings, Protocol Development, Data Quality Monitoring, CRO Management, Validation Support, Drug In-licensing, Health Authority Responses

Industry

Staffing and Recruiting

Description
JOB DESCRIPTION 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. 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
Responsibilities
The role involves performing statistical activities for clinical trials, from protocol development and sample size calculation to final study reports. It also includes managing regulatory filings, monitoring CRO deliverables, and collaborating with cross-functional teams to ensure data quality.