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 of the job include but are not limited to:

• 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.)