Principal Biostatistician, Clinical Trials - remote

REQUIRED QUALIFICATIONS:

Knowledge of: 

• Knowledgeable and experienced in clinical trial methodology.
• Experience and knowledge of clinical data management processes and tools (Medidata Rave and Veeva preferred).
• Demonstrated practical understanding of fundamental statistical concepts and methodologies.
• Proven knowledge of research study design methods, independent problem solving, decision making, and principles, concepts, methods, and standards of statistical analyses.
• Demonstrated ability to explain statistical concepts to non-statisticians to enhance their understanding of the analytical approach.
• Proficiency in statistical methods used to design and assess outcomes of clinical trials.
• Strong research and analysis skills including an understanding of scientific/therapeutic research in general.
• Advanced analytical skills, including high-level experience with SAS.

 Ability to:

• Perform SAS programming and statistical analyses for research projects independently.
• Utilize excellent problem-solving skills, with a positive attitude that allows all problems to be broken into manageable parts and tackled.
• Employ excellent written and communication skills, including the ability to provide meticulous documentation of processes and organize materials in a transparent manner.
• Utilize organizational skills and ability to manage multiple projects while meeting deadlines.
• Demonstrate basic Microsoft Office computer software and Internet skills.
• Commit to occasional overnight travel.

Education/Experience:

• PhD degree in relevant field with 5+ years in statistical design and analysis of clinical or biomedical studies  or Master’s degree in relevant field with 8+ years of experience.  

• Experience designing and analyzing Phase I-Phase IV clinical trials. 

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)

• Preference given to candidates with working knowledge of GCP and FDA regulations, experience working in the pharmaceutical/medical device industry and working knowledge of SDTM/ADaM standards.
• Excellent interpersonal skills that can enable enjoyable collaboration with diverse study staff and investigators.
• Demonstrated success working/collaborating with diverse populations in a role that has focused on improving health equity by working to eliminate health disparities and/or addressing systemic racism. 

BENEFITS:
NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees. Please reference this link for more information: NMDP Benefit Information