Seeking a remote Associate Director of Biostatistics to lead statistical activities for clinical trials at an innovative biotech company.
Job Detail
Job Description
Key Responsibilities:
- Represent biostatistics in cross-functional team meetings to drive clinical development strategies.
- Collaborate with Clinical Development, Regulatory, and Clinical Operations teams to design clinical trials.
- Author statistical sections of clinical trial protocols in consultation with internal and external experts.
- Prepare or contribute to statistical analysis plans.
- Work with Data Management and Clinical Operations to design eCRFs.
- Provide statistical guidance on the execution of ongoing trials.
- Partner with Statistical Programmers on data summaries and analyses.
- Write specifications for analysis datasets (ADS) and ad hoc analyses.
- Contribute to clinical study reports and other regulatory documents, such as DSURs and briefing documents.
- Engage with regulatory authorities, Key Opinion Leaders, partners, and other stakeholders.
- Contribute to scientific publications summarizing clinical trial data.
- Participate in Biostatistics and Development Team activities and meetings.
- Provide statistical consultation to Research and Preclinical teams.
- Manage CRO statistical and programming support.
Qualifications:
- Ph.D. in Biostatistics, Statistics, or a related field with 7+ years of pharmaceutical biostatistics experience, or MS with 10+ years of relevant experience.
- Strong written and verbal communication and presentation skills.
- Proficiency in SAS programming.
- Basic understanding and interest in biology and biological processes.
Preferred Experience:
- Clinical development experience through Phase 3, including NDA submissions.
- Experience as a lead statistician for a compound.
- Familiarity with ICH GCP and industry standards.
- Proficiency in R and other statistical software (e.g., EAST).
- Knowledge of CDISC standards, including SDTM, ADaM, and CDASH.
- Experience with adaptive trial designs.
- Representation of sponsors in regulatory interactions with the FDA and international authorities.
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