Phastar · 8 hours ago
Senior Statistician
United States
Full-time
Remote
Senior Level, Lead/Staff
5+ years expPhastar is an award-winning biometrics and data science CRO, trusted by pharma, biotech, and medical device companies worldwide. The Senior Statistician will be a key contributor within the FSP Team, supporting US-based pharmaceutical clients by producing and validating datasets and outputs for clinical trials.
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
SAP/shell creation and review
Qualification
Required
Educated to PhD or MSc in Biostatistics/Statistics or a closely related field
Extensive CDISC experience (SDTMs and ADaMs)
5-7+ years' experience working within a CRO or pharmaceutical setting
Solid statistical knowledge and capability in statistical analysis (eg. binary and continuous data analysis, missing data handling, etc.)
Proficient in SAS, R experience is advantageous also
Previous experience working as a Lead Statistician
Previous experience with SAP/shell creation and review
Cross-functional experience
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 and/or Immunology experience is advantageous, but not essential
Experience in outcomes is advantageous, but not essential
Previous experience in authoring and reviewing SAP/TLF shells
Previous experience in reviewing and validating ADaM/TLFs for DMC, IA and CSR
Benefits
Remote working and flexible working hours
Career development, mentorship, and continuous learning
Supportive, friendly, and collaborative culture
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