ClinChoice · 1 day ago

Manager, Statistical Programmer Consultant-Remote

Connellsville, PA

Full-time

Remote

Senior Level, Lead/Staff

9+ years exp

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Responsibilities

Work directly for a single sponsor while leveraging the security of a global CRO.

Establish a high-trust environment with the client's counterparts.

Effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies.

Qualification

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Sc. in StatisticsClinical trial data processingSAS programmingStatistical analysisRegulatory submissionBiostatisticsComputer ScienceClinical trial regulatory knowledgeICH requirements knowledgeData standardizationProcess designHigh-trust environment

Required

M.Sc., or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.

Minimum 9 years' experience with in-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies.

Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented.

Knowledge of clinical trial regulatory and ICH requirements.

Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies.

Must possess in-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations.

Must have sound technical judgment and experience in process design and implementation in relevant areas.

Strong leadership and drive to achieve goals will be required.

Company

ClinChoice

Glassdoor

3.7

ClinChoice is a full-service global clinical CRO dedicated to offering high-quality, efficient and flexible solutions to pharmaceutical, biotechnology, medical device, and consumer products clients worldwide.

Founded in 1995

Shanghai, Shanghai, CHN

1001-5000 employees