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Rapport

Senior Manager/Associate Director, Biostatistics

RemoteUnited States only
Published
Role
Data Science
Experience
Senior
$200k–$220k/yr
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Open to US only. Set where you work from to check your eligibility.

No BS summary

Senior biostatistics leader for CNS clinical drug development, with PhD/MS plus 3–9+ years depending on level. Must know clinical trial design, regulatory guidelines, CDISC SDTM/ADaM, and be hands-on with SAS or R. Remote role supporting the Bipolar Mania program.

Core skills

SAS/RBiostatistics

Required skills

CDISCSDTMADaM

What you'll do

  • Working as a leading statistician on multiple studies/projects.
  • Oversee the production of protocol development (study design, endpoint selection, sample size calculation and statistical methods) and Statistical Analysis Plan (SAP) that lead to comprehensive clinical study reports suitable for regulatory submissions.
  • Provide strategic statistical leadership across development programs, influencing study design, data-driven decision-making, and regulatory strategies.
  • Support statistical programming to plan, execute and deliver SDTM and ADaM datasets, tables, listings, and figures (TLFs).
  • Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH, FDA, EMA).
  • Provide statistical input and the interpretation of results to clinical study reports, regulatory submissions documents, and publications, in collaboration with the clinical, regulatory, and medical affairs teams.
  • Perform and validate statistical analyses of clinical trial data using SAS and/or R in accordance with regulatory and internal standards.
  • Participate in the development and review of case report forms (CRFs) and data management plans to ensure accurate data collection aligned with study objectives.
  • Oversee and manage external CROs and vendors to ensure high-quality and timely deliverables.
  • Serve as the biometrics representative on cross-functional team, providing statistical support and insights to influence decision-making.

What they require

  • Senior Manager: PhD with 3+ or MS with 6+ years of biostatistics experience
  • Associate Director: PhD with 6+ years or MS with 9+ years of biostatistics experience
  • Experience in the CNS drug development and expertise in survival analysis and/or adaptive design is highly desirable
  • Skilled in scientific programming including SAS or R for data analysis, graphing, and simulation
  • Comprehensive knowledge of clinical trial design, advanced statistical analysis methods, and familiarity with regulatory guidelines (FDA, EMA, ICH)
  • Extensive knowledge of CDISC standards (SDTM, ADaM) and industry best practices for data collection, analysis, and reporting
  • Ability to communicate complex statistical concepts clearly to non-statistical audiences.
  • Ability to manage multiple projects in a fast-paced environment, flexibility to adapt to changing priorities and timelines
  • Ability to effectively collaborate with internal stakeholders and manage the statistical work of external stakeholders/vendors

Benefits

  • Every role has meaning.
  • We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
  • We are driven to innovate.
  • Exciting science that pushes boundaries and opens new possibilities.
  • Your perspective matters.
  • Stick your neck out, share your ideas – we work as a team.
  • We have FUN.
  • We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
  • Leadership that CARES – about you, your growth + development.
  • We're bicoastal.
  • Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
  • Competitive benefits.
  • Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
  • You get to be YOU!
  • Show up as you are and make every day count.
  • In addition to a competitive salary, we also offer a pretty great benefits package.
  • We share our full salary ranges for every level across our company.

Rapport is developing precision neuromedicines using a scientific platform centered on Receptor Associate Proteins (RAPs), with lead program RAP-219 targeting focal epilepsy and additional trials in PGTCS and bipolar disorder.

Biotech
$200k–$220k/yr