Associate Statistical Project Leader
Sanofi
4 hours ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Main Responsibilities:
- Provide high-quality input into clinical study design (including protocol development) and support setup/conduct to capture data for study objectives and planned statistical analyses.
- Accountable for statistical deliverables: protocol statistical sections (sample size calculation, randomization specifications, statistical methodology), Statistical Analysis Plan (SAP), data surveillance, and statistical results for CSR and appendices.
- Utilize external groups (e.g., CROs, data monitoring committees/DMC).
- Partner with programming team on derived variable definitions/documentation, review, and quality control plan.
- Perform and/or coordinate statistical analysis production; review and examine statistical data distributions/properties.
- Oversee execution of statistical analyses per SAP; provide statistical methods and insight for CSR/publication interpretation and discussion in line with internal standards, regulatory guidelines, and SOPs.
- Propose, prepare, and perform exploratory and ad-hoc analyses relevant to study/project objectives.
Qualifications/Requirements:
- MS in Statistics (or related quantitative discipline).
- Minimum 3 years of pharmaceutical experience in clinical development (e.g., biotech/pharma, CROs, health authorities, or academic clinical research).
Preferred:
- PhD in Statistics (or related quantitative discipline).
- Experience with late-stage clinical trials.
Skills:
- Advanced statistical concepts/techniques; proficiency performing analyses using SAS or R.
- Proficient in written and spoken English.
Benefits (explicitly stated):
- Health and wellbeing benefits including high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Provide high-quality input into clinical study design (including protocol development) and support setup/conduct to capture data for study objectives and planned statistical analyses.
- Accountable for statistical deliverables: protocol statistical sections (sample size calculation, randomization specifications, statistical methodology), Statistical Analysis Plan (SAP), data surveillance, and statistical results for CSR and appendices.
- Utilize external groups (e.g., CROs, data monitoring committees/DMC).
- Partner with programming team on derived variable definitions/documentation, review, and quality control plan.
- Perform and/or coordinate statistical analysis production; review and examine statistical data distributions/properties.
- Oversee execution of statistical analyses per SAP; provide statistical methods and insight for CSR/publication interpretation and discussion in line with internal standards, regulatory guidelines, and SOPs.
- Propose, prepare, and perform exploratory and ad-hoc analyses relevant to study/project objectives.
Qualifications/Requirements:
- MS in Statistics (or related quantitative discipline).
- Minimum 3 years of pharmaceutical experience in clinical development (e.g., biotech/pharma, CROs, health authorities, or academic clinical research).
Preferred:
- PhD in Statistics (or related quantitative discipline).
- Experience with late-stage clinical trials.
Skills:
- Advanced statistical concepts/techniques; proficiency performing analyses using SAS or R.
- Proficient in written and spoken English.
Benefits (explicitly stated):
- Health and wellbeing benefits including high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.