A leading organization is currently seeking an Associate Director of Biostatistics to join their team in New York, offering a remote work setup. This position involves providing technical leadership and biostatistical support in the design and execution of clinical studies.
About the Opportunity:
- Hybrid or Remote: Remote
- Shift: Standard business hours
- Schedule: Full-time
- Hours: 40 hours per week
- Setting: Remote with occasional on-site requirements
Responsibilities:
The Associate Director of Biostatistics will be responsible for:
- Leading tasks at the indication/study level, including regulatory interactions, ensuring statistical integrity, and contributing strategically to projects.
- Contributing to study design, sample size determination, and authoring statistics sections in protocol documents.
- Collaboratively working within biometrics and cross-functional teams to meet deliverables and timelines.
- Ensuring statistical integrity of deliverables and providing scientifically sound methodology input to meet project objectives.
- Independently conducting data analyses and proposing new statistical methodologies to improve study efficiency.
Qualifications:
- 5 years of experience with a PhD in Statistics or Biostatistics, or 8 years with a Master's degree in the clinical trials setting within the pharmaceutical industry.
- In-depth experience with NDA/BLA/MAA activities and direct involvement in regulatory interactions.
- Experience as a study lead statistician with contributions to strategy discussions in cross-functional settings.
- Familiarity with ICH guidelines and regulatory authority guidance such as FDA/EMA.
- Proficiency in SAS and R, with knowledge in CDISC including SDTM, ADaM, and controlled terminologies.
- Detail-oriented with strong organizational, problem-solving, and prioritization skills.
Desired Skills:
- 5 years of experience in Phase 2 and 3 clinical trials
- Master's degree in Statistics or Biostatistics
- Knowledge of Clinical Data Interchange Standards Consortium (CDISC)
- Proficiency in Statistical Analysis System (SAS)
- Strategic thinking and strong leadership skills
