Senior Principal Statistics at Lumiere Systems

Paramus, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Jul, 26

Salary

0.0

Posted On

12 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Statistics, Biostatistics, SAS, Clinical Trials, Protocol Development, Regulatory Filings, CDISC, FDA Guidelines, ICH Guidelines, Data Quality, Sample Size Calculation, Statistical Analysis Plan, Database Design, Leadership, Problem-solving

Industry

IT Services and IT Consulting

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 QUALIFICATIONS: 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 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

Responsibilities

The Senior Principal Statistics manager oversees statistical activities for clinical trials, ranging from protocol development to regulatory filings and marketing support. They collaborate with cross-functional teams and vendors to ensure data quality, monitor study conduct, and provide statistical validation for study reports.