Phastar · 2 days ago
Senior/Principal Statistician
United States
Full-time
Remote
Senior Level, Lead/Staff
5+ years expPhastar is a global biometric Contract Research Organization (CRO) recognized for its commitment to quality and employee satisfaction. They are seeking an experienced Statistician at the Senior or Principal level to support clinical trials in areas such as GI, Immunology, or Oncology, focusing on producing and validating complex statistical outputs while adhering to timelines.
BiotechnologyData ManagementLife ScienceMedical DevicePharmaceutical
Hiring Manager
Rebecca McMahon
Responsibilities
Program and validate complex primary efficacy datasets
Program and validate complex summary tables, listings and figures, program statistical analysis tables, according to the SAP
Liaise with clients to propose alternatives or additional analyses if needed
Develop and validate macros for statistical analyses and figures
Perform stage 3 QC
Advise on complex analyses and endpoints; ensure consistency across clinical trial program
Create, validate and QC of efficacy dataset specifications for single studies, ISS/ISEs, etc
Write ISS/ISE SAPs; DSMB SAPs and Charters
Write project level or therapeutic area level documentation
Perform QC of SAP text and develop standard SAP text and templates to be used within the company
Identify the need and provide review of new standards and project level shells ensuring consistency across clinical trial programs
Write statistical section of protocol for any study
Provide statistical consultancy at study design stage or during program development
Conduct independent critical protocol review
Consult with clinical scientists to decide on best approach for sample size calculation, and execution
Perform QC of sample size calculations
Perform complex simulations
Create complex randomisation schemes and QC of complex randomisation schemes
Work as unblinded DSMB statistician involved with liaising with committee members
Distribute and communicate interim analyses to appropriate stakeholders
Attend meetings as the independent statistician on the DSMB committee
Coordinate and lead clinical interpretation meetings
Complete clinical trial transparency forms and input into project level regulatory documentation
Senior review of CSR
Archive study documentation following instructions in supplied SOPs
Prioritise quality in all activities undertaken, by ensuring the principles in the PHASTAR checklist are followed
Create, review and update processes and SOPs, identify areas where new processes are required
Qualification
Required
Educated to PhD or MSc in Biostatistics/Statistics or a closely related field
5+ years of experience within a CRO setting or pharmaceutical/biotechnology company
Solid statistical knowledge and capability in statistical analysis (eg. binary and continuous data analysis, missing data handling, etc.)
Extensive CDISC experience (SDTMs and ADaMs)
Experience of writing SAPs, protocols
Cross-functional experience
Previous experience working as a Lead Statistician
Proficient in SAS
Ability to work independently and collaboratively in a fast-paced environment
Preferred
Experience in novel study design, Bayesian statistics, or complex statistical analysis/modeling/simulations is advantageous, but not essential
Previous GI, Immunology and/or Oncology experience is advantageous, but not essential
Experience in outcomes is advantageous, but not essential
Experience in late-phase (phase 2 and phase 3 studies) and submission work is advantageous, but not essential
R software experience is advantageous, but not essential
Benefits
Flexible working
Part-time hours
Involvement in developing company-wide initiatives
Structured training and development plans
Continuous learning opportunities
Competitive salary and benefits package
Company
Phastar
Phastar is specialist biometrics CRO, offering statistical consulting, clinical trial reporting, data science and data management services.
201-500 employees
H1B Sponsorship
Phastar has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Charterhouse Capital Partners
2021-01-05Private Equity
Leadership Team
April Romano
Senior Human Resources Business Partner
Chuck Gelb
Chief Commercial Officer
Recent News
2025-05-17
2025-02-13
Company data provided by crunchbase