Principal Biostatistician (FSP - Permanent Homebased)

Job Responsibilities:

1. Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
2. Write the statistical sections of clinical trial protocols, while consulting with internal and external experts.
3. Write statistical analysis plans.
4. Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
5. Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
6. Contribute to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, etc.
7. Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures.
8. Interpret study results and review reports of study results for accuracy.
9. Support exploratory analyses and medical affairs publications.
10. Participate in pre-IND and NDA activities.
11. Participates in other activities and meetings to support Biostatistics and the Development Team as needed.

Qualifications (Minimal acceptable level of education, work experience, and competency):

1. PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
2. MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
3. Strong early phase (Phase I) experience.
4. Demonstrated ability to work independently in project management and decision making.
5. Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
6. Ability to use SAS and/or R to perform efficacy analyses and validate important data derivations when necessary.
7. Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
8. Experience with CDISC, including SDTM, Adam, CDASH.
9. 1+ years with regulatory submissions.

Desired Experience:

1. Familiarity with R programming language and other statistical software.