Principal Statistician
About The Position
Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services. We're proud of the impact we make and just last year, we supported over 780 discovery projects , 1,000+ CMC programmes , and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers . To learn more, visit www.pharmaron.com . Job Overview: 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.
Requirements
- 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.
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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
