Associate Statistical Project Leader
Sanofi
4 hours ago
Remote friendly (Morristown, NJ)
United States
Clinical Research and Development
Main Responsibilities:
- Provide high-quality input into clinical study design (including protocol development), setup, and conduct to ensure data capture/collection supports study objectives and planned statistical analyses.
- Accountable for statistical deliverables, including protocol statistical sections (sample size calculation, randomization specifications, statistical methodology), Statistical Analysis Plan (SAP), data surveillance, and statistical analysis results for CSR and appendices.
- Effectively utilize external groups (e.g., CROs, data monitoring committees [DMC]).
- Work with the programming team to define, document, and review derived variables and support the quality control plan.
- Perform and/or coordinate with study programmer production of statistical analyses; review and assess statistical data distributions/properties.
- Oversee execution of statistical analyses per SAP; prepare statistical methods and provide statistical insight for interpretation/discussion of CSR/publication results to ensure statistical integrity and validity per internal standards, regulatory guidelines, and SOPs.
- Propose, prepare, and perform exploratory and ad-hoc analyses as relevant to study/project objectives.
Qualifications:
- PhD in Statistics or related quantitative discipline strongly preferred (advanced statistical methodology); MS in Statistics or related discipline required.
- Minimum 3 years of pharmaceutical experience in clinical development (e.g., biotech/pharma, CROs, health authorities, or academic clinical research centers).
- Highly preferred: Experience with late-stage clinical trials.
- Broad knowledge of advanced statistical concepts and techniques; ability to perform advanced analyses using SAS or R.
- Proficient in written and spoken English.
- Provide high-quality input into clinical study design (including protocol development), setup, and conduct to ensure data capture/collection supports study objectives and planned statistical analyses.
- Accountable for statistical deliverables, including protocol statistical sections (sample size calculation, randomization specifications, statistical methodology), Statistical Analysis Plan (SAP), data surveillance, and statistical analysis results for CSR and appendices.
- Effectively utilize external groups (e.g., CROs, data monitoring committees [DMC]).
- Work with the programming team to define, document, and review derived variables and support the quality control plan.
- Perform and/or coordinate with study programmer production of statistical analyses; review and assess statistical data distributions/properties.
- Oversee execution of statistical analyses per SAP; prepare statistical methods and provide statistical insight for interpretation/discussion of CSR/publication results to ensure statistical integrity and validity per internal standards, regulatory guidelines, and SOPs.
- Propose, prepare, and perform exploratory and ad-hoc analyses as relevant to study/project objectives.
Qualifications:
- PhD in Statistics or related quantitative discipline strongly preferred (advanced statistical methodology); MS in Statistics or related discipline required.
- Minimum 3 years of pharmaceutical experience in clinical development (e.g., biotech/pharma, CROs, health authorities, or academic clinical research centers).
- Highly preferred: Experience with late-stage clinical trials.
- Broad knowledge of advanced statistical concepts and techniques; ability to perform advanced analyses using SAS or R.
- Proficient in written and spoken English.