Our client is a biopharmaceutical company focusing on therapeutics for muscle disease and is looking for a Director of Biostatistics to join their team!
$160k – $240k
The Director of Biostatistics will be responsible for authoring statistical protocols, preparing statistical analysis plans, interpreting and communicating results.
- Contribute to clinical study reports
- Design stratification and randomization schemes
- Collaborate with internal and external teams to plan and execute statistical deliverables
- Be the biostatistics expert for clinical studies
- Validate results of statistical deliverables
- Originate and manage the development of statistical analysis plans for clinical trials and summaries of safety (ISS/ISE)
- Add contributions to clinical study reports and additional regulatory documents as needed
- Responsible for statistical needs that contribute to IND/NDA/MAA and additional regulatory submissions
- Respond to FDA and regulatory agency statistical questions and comments
- Attend meetings to provide statistical explanations to external parties and regulatory agencies as needed
- Add to the clinical development and methodologies as needed from a statistical perspective
- 5+ years of pharmaceutical or biotech industry experience
- Experience in NDAs, MAAs or other submissions
- Knowledge of statistical methods for clinical trials
- SAS and trial design software experience required, R experience is a plus
- An understanding of SDTM and ADaM data standards
- PhD in Statistics or Biostatistics
As a woman-owned firm, we value diversity. We are an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, genetic information or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
