Pharmaron · 3 weeks ago
Principal Statistician
Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. The Principal Statistician will develop and review statistical sections of study protocols, perform statistical calculations, and ensure compliance with quality standards in clinical trials.
BiotechnologyChemicalPharmaceutical
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 on understanding of statistical design, and the implementation of statistical models
Mentor Biostatisticians with statistical relevant work
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
Required
Master degree or above in biostatistics, statistics, mathematics, or relevant scientific disciplines preferred, or Bachelor degree with an equivalent amount of experience can be substitute as appropriate
5+ years relevant experience in clinical trial statistics
Familiar with SAS Base, SAS/Macros, SAS/Graph, SAS/Stat and reporting process
Familiar with CDISC CDASH/SDTM/ADaM standards
Compliance in SOPs/WIs, ICH-GCP and any other applicable local and international regulations, guidelines and industry standards
Benefits
Insurance including Medical, Dental & Vision with significant employer contributions
Employer-funded Health Reimbursement Account
Healthcare & Dependent Care Flexible Spending Accounts
100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance
401k plan with generous employer match
Access to an Employee Assistance Program
Company
Pharmaron
Pharmaron is a contract research organization that offers research and development services for the life science industries.
Funding
Current Stage
Public CompanyTotal Funding
$907.82MKey Investors
GL Capital
2019-11-22Post Ipo Equity· $587.82M
2019-01-28IPO
2015-12-14Series Unknown· $280M
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