Principal Biostatistician/Senior Principal Biostatistician

About the role

Provides statistical leadership and support for all phases of clinical development. Responsibilities include consulting with clients on clinical trial study design and regulatory strategy, writing and reviewing statistical methods and sample size sections of protocols, developing statistical analysis plans for complex study designs, reviewing statistical analyses, and presenting results.

Responsibilities

• 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
• Lead complex programs such as NDA/BLA/MAA submissions or complex, multi-protocol programs and provide statistical oversight
• Other duties as assigned

Requirements

• Broad experience with regulatory submissions
• Extensive experience consulting with clients regarding clinical trial study design and regulatory strategy
• Superior understanding of 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
• Competency in written and spoken English
• Ability to establish and teach others to maintain effective working relationships with coworkers, managers, and clients
• Follow and train others on applicable regulations, including FDA, ICH, and company policies and procedures
• Promote the company image and act as an ambassador
• Ensure all internal systems are routinely updated as appropriate (e.g., timesheets, expense reports, financial reports)

Qualifications

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 of experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years of experience.

Skills

• Excellent communication and interpersonal skills
• Excellent problem-solving skills
• Excellent presentation skills
• Excellent organizational and time management skills
• Outstanding statistical skills
• Sound judgment and decision-making ability
• Service-oriented, accountable, and flexible

Preferred Experience

• Oncology and rare diseases
• Data Monitoring Committees (DMCs)

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation

Pay

Reasonable estimate of the current range: $147,300 USD - $243,000 USD.