Top 3 Principal statistical programmer Jobs in Ridgefield, Nj

Senior Principal Statistical Programmer
Katalyst Healthcares & Life Sciences —Paramus, NJ
- Contract
- 6 years
- Doctor of Philosophy
- Organizational skills
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Principal Statistical Programmer (Remote)
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Must have sound technical judgment and experience in process design and implementation in relevant areas. Perform hands on primary statistical programming and…
$112,000 - $175,000 a year
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Senior Principal Statistical Programmer

Katalyst Healthcares & Life Sciences -
Paramus, NJ

Quick Apply

Job Details

Contract

Qualifications

SAS
Team leadership
Data structures
Drug regulation
SAS language
Schedule management
CDISC standards
Managing clinical research teams
Achieving project delivery timelines
Leading research teams
Senior leadership

Full 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:

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

Must have:

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

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Senior Principal Statistical Programmer

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