Pharmaron · 12 hours ago

Principal Statistician - Remote USA

United States

Full-time

Remote

Lead/Staff

8+ years exp

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BiotechnologyChemical

Hiring Manager

Zoe Sones (🟡🔴🟢🔵)

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Responsibilities

Develop and/or review statistical sections of a study protocol with high complexity independently.

Perform and/or verify sample size and statistical power calculation for typical trial designs.

Develop statistical analysis plans, table/listings/figures mock-ups and statistical analysis reports for a study with different complexity.

Act as a randomization statistician to develop the randomization protocol and generate the randomization schedule.

Attend client meetings including, but not limited to, project kick-off meetings, resource/timelines discussions, bid defenses, blind data review meetings etc.

QC/review case report form and other DM documents including, but not limited to edit check specifications, data review plan, data transfer specification and etc.

QC/review programming deliverables including, but not limited to programming specifications, analysis datasets and TLFs and etc. to ensure to meet the analysis requirements.

Mentor statistical programmers and Biostatisticians

Ensure all activities in accordance with internal and external quality standards, SOPs/WIs, ICH-GCP and/or any other applicable local and international regulations, guidelines and industry standards.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Degree in StatisticsClinical trial statistics experienceSAS Base proficiencySAS/Macros proficiencySAS/Graph proficiencySAS/Stat proficiencyStatistical analysis plansFDA regulations knowledgeProject management