Sr. Principal Statistics
Actalent
Paramus, NJ (In Person)
$187,200 Salary, Full-Time
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Job Description
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 reviewSAP, 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 Additional Skills & Qualifications 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 Experience Level Intermediate Level- Must be willing to be on site 5x/week in Paramus, New Jersey
- Job Type & Location This is a Contract position based out of Paramus, NJ.
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Paramus,NJ.
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