Principal Biostatistician​/Senior Principal Biostatistician

Position Summary  Provides statistical leadership and support for all phases of clinical development. Specific responsibilities include consulting with clients regarding clinical trial study design and regulatory strategy, writing and reviewing statistical methods and sample size sections of protocols, writing and reviewing statistical analysis plans of complex study designs, reviewing statistical analyses and presenting statistical results. Lead complex programs such as NDA/BLA/MAA submissions or complex, multi-protocol programs and provide statistical oversight.

Serve as a subject matter expert for one or more areas (e.g., Bayesian adaptive study design, Survival analysis, DMC, submissions).
Essential Functions   Consult with clients regarding clinical trial study design and regulatory strategy
Develop and review statistical methods of clinical study protocols
Provide and/or verify sample size calculations
Author statistical analysis plans of complex study design
Review statistical analysis plans written by other biostatisticians
Review statistical output to ensure accuracy
Review statistical sections of clinical study reports
Generate and/or verify randomization schedules
Provide statistical analysis and reporting to Data Monitoring Committees (DMCs) as the unblinded reporting biostatistician
Work proactively with sponsors, internal study team, and external vendors
Serve as a Subject Matter Expert (SME) and develop/review procedural documents and work on new initiatives
Provide mentoring and training to other statisticians
Attend bid defense meetings for complex programs
Other duties as assigned
Qualifications   Minimum

Required:

Senior Principal Biostatistician level:
Master's degree or equivalent in Statistics, Biostatistics, or related field with 12+ years of experience;
PhD degree in Statistics, Biostatistics, or related field with 9+ years of experience. Principal Biostatistician level:
Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience;
PhD degree in Statistics, Biostatistics, or related field with 7+ years experience.
Other Required   Broad experience with regulatory submissions
Extensive experience consulting with clients regarding clinical trial study design and regulatory strategy
Superior understanding of a statistical methodology (e.g., Bayesian adaptive study design, Survival analysis, Repeated measures)
Sound knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines

Experience with SAS
Preferred   

Experience with oncology and rare diseases

Experience with DMCs
Excellent communication and interpersonal skills
Excellent problem‑solving skills
Excellent presentation skills
Excellent organizational and time management skills
Outstanding statistical skills
Competencies   Sound judgment/decision making
Ability to establish and teach others to maintain effective working relationships with coworkers, managers, and clients
Service oriented, accountable, and flexible
Competency in written and spoken English
Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures
At all times to promote the image of Precision, acting as an ambassador to the Company
Ensure that all internal systems are routinely updated as appropriate (e.g., timesheets, expense reports, financial reports, etc.)
Salary & Benefits   Salary Range: ,000
discretionary annual bonus
health insurance
retirement savings benefits
life insurance and disability benefits
parental leave
paid time off for sick leave and vacation
among other benefits.
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