Biostatistician Resume Example
Bell-curve layout: a distribution-histogram mark, trial and submission metrics and a study-analysis table for clinical biostatisticians.
Use this example Template: Biostatistician
Inês Carvalho
Senior Biostatistician — Clinical Trials, CDISC & Regulatory Submissions
ines.carvalho@example.com+351 912 555 734Lisbon, Portugallinkedin.com/in/inescarvalho-stats
8Years in trials
14Lead studies
2Approvals
9Publications
Summary
Biostatistician with 8 years in oncology and vaccine trials at a CRO and a pharma sponsor. I write statistical analysis plans, design adaptive and group-sequential trials, run sample-size and interim analyses, and deliver CDISC ADaM datasets and TLFs for submissions. I have been lead statistician on 14 phase I–III studies and 2 approved marketing applications, and I answered agency questions with no major objections.
Experience
Senior Biostatistician
Hovione · Lisbon
Jan 2021 – Present
14Lead studies
2Approvals
−30%Sample size via adaptive design
- Lead statistician on 6 phase II–III oncology trials: protocol design, SAP, randomisation and DSMB analyses
- Designed a Bayesian adaptive dose-finding study that needed 30% fewer patients than the fixed design
- Own the CDISC ADaM and TLF package for 2 marketing applications, passing Pinnacle 21 checks with no rejects
- Mentor 4 statisticians and review SAS and R programming for all study deliverables
Biostatistician
ICON plc · Lisbon
Sep 2017 – Dec 2020
8Vaccine studies
- Analysed immunogenicity and safety for 8 vaccine studies, including non-inferiority and lot-consistency endpoints
- Wrote sample-size calculations and SAP sections for 20+ protocols across 5 sponsors
- Built an R Shiny tool for blinded data review, adopted by 3 study teams
Research Statistician
Instituto de Medicina Molecular · Lisbon
Oct 2015 – Aug 2017
- Modelled survival and longitudinal outcomes for epidemiology cohorts with 40,000 participants
- Co-authored 9 peer-reviewed papers as study statistician
Selected studies
| Study | Design | N |
|---|---|---|
| Phase III NSCLC | Group-sequential | 812 |
| Phase I/II dose-finding | Bayesian adaptive | 96 |
| Phase III vaccine | Non-inferiority | 3,400 |
| Phase II breast cancer | Randomised, 2-arm | 240 |
Summary example
Biostatistician with [N] years in oncology and vaccine trials at a CRO and a pharma sponsor. I write statistical analysis plans, design adaptive and group-sequential trials, run sample-size and interim analyses, and deliver CDISC ADaM datasets and TLFs for submissions. I have been lead statistician on [N] phase I–III studies and [N] approved marketing applications, and I answered agency questions with no major objections.
Example bullet points for a Biostatistician
- Lead statistician on [N] phase II–III oncology trials: protocol design, SAP, randomisation and DSMB analyses
- Designed a Bayesian adaptive dose-finding study that needed [X%] fewer patients than the fixed design
- Own the CDISC ADaM and TLF package for [N] marketing applications, passing Pinnacle [N] checks with no rejects
- Mentor [N] statisticians and review SAS and R programming for all study deliverables
- Analysed immunogenicity and safety for [N] vaccine studies, including non-inferiority and lot-consistency endpoints
- Wrote sample-size calculations and SAP sections for [N]+ protocols across [N] sponsors
- Built an R Shiny tool for blinded data review, adopted by [N] study teams
- Modelled survival and longitudinal outcomes for epidemiology cohorts with [N] participants
Replace the [brackets] with your own numbers and facts. Never claim results you didn't achieve.
Skills to include
- Adaptive & group-sequential design
- Survival & mixed models
- CDISC SDTM / ADaM
- ICH E9(R1) estimands
- SAS
- R
- East
- Pinnacle 21
- Git
Tips for a Biostatistician resume
- Put the hard requirements recruiters screen for in the top third: Adaptive & group-sequential design, Survival & mixed models, CDISC SDTM / ADaM.
- List current credentials with the issuing body, e.g. SAS Certified Clinical Trials Programmer, Accredited Statistician (CStat).
- Give every recent role at least one measured result — for example lead studies.
- Match the job title in your headline to the posting where it is honest to do so.
- Run the built-in resume checker and paste the job description into the keyword match before you download.
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