FSP Senior/Principal Statistician - GI

As a Senior/Principal Statistician you’ll be a key contributor within our FSP Team and will support one of our fantastic US-based pharmaceutical clients, focusing on GI studies. You will work on clinical trials; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. You will be responsible for producing and reviewing Statistical Analysis Plans (SAPs), protocols and other pertinent study documentation. You will join the team at Senior or Principal level, depending on experience, will work full time, be a permanent employee and will be fully remote.

Please note that due to internal restrictions the successful candidate must be located in one of the following US States: Massachusetts, New Jersey, New York, Pennsylvania, North Carolina, Texas or California.

• 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

• 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
• 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
• Ability to work independently and collaboratively in a fast-paced environment

Why Join Us

• Remote working and flexible working hours
• Career development, mentorship, and continuous learning
• Supportive, friendly, and collaborative culture
• Making a Positive Impact: As a B-Corp organization, we are committed to sustainability, solid responsibility and strong ethical governance through our ESG initiatives

About Phastar

Phastar is an award-winning biometrics and data science CRO, trusted by pharma, biotech, and medical device companies worldwide. With a global team of data specialists, we bring expertise, precision, and pace to every trial, because behind every data point is a patient waiting for treatment.

We transform complex data into clear, actionable intelligence, helping accelerate drug development, and bring life-changing therapies to patients faster.

Awards & Recognition

• SCRIP – Best Contract Research Organization, Specialist Provider
• Citeline – 2025 Award Winner
• Fierce CRO Awards – Recognized Industry Leader

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Be part of a team known for technical expertise, quality, and impact. We value Excellence, Collaboration, Integrity, Innovation, and Passion—and we seek team members who embody these qualities. Apply today!

Phastar is committed to the principles and practices of equal opportunities and to encourage the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, color, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.

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