Sr. Principal Biostatistician

Neurocrine Biosciences • San Diego, CA

1d

About The Position

Serves as the overall statistical lead on one or more clinical programs and provides strategic input in the design, statistical analysis, and reporting of clinical studies to expedite the conduct and evaluation of clinical trials and basic research. Leads statistical analysis and maintains standards across studies within a clinical program. Interacts with key opinion leaders on protocol design. Maintains expertise in new and innovative statistical analysis methodology.

Requirements

• Master’s degree in statistics, biostatistics or related discipline AND 6+ years of experience with Phase 1 through Phase 4 clinical studies and observational studies, and the development of drug development strategies in the pharmaceutical industry setting, particularly the design, analysis and reporting of clinical studies. Demonstrated experience in SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data. Direct experience interacting with regulatory authorities.
• OR PhD in statistics, biostatistics or related discipline AND 4+ years of similar experience noted above.
• Considered an expert within the company and may have external presence in area of expertise
• Applies knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
• Ability to work as part of and lead multiple teams
• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams.
• Excellent computer skills
• Excellent communications, problem-solving, analytical thinking skills.
• Sees broader picture and longer-term impact on division/company.
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Excellent project management, strong project leadership skills.
• Significant expertise in the design, analysis, and reporting of clinical studies, including innovative and adaptive study designs and advanced statistical analysis methods
• Demonstrated ability to provide statistical leadership and strategic input regarding the overall drug development plan and commercialization activities
• Excellent organizational skills and proven ability to effectively lead a project to successful completion
• Advanced knowledge of the SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data
• Advanced knowledge of working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets
• Thorough knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data
• Experience in interacting directly with regulatory authorities in meetings and written communications

Responsibilities

• Provides statistical leadership and strategic input to the Dev Core Team in all areas of drug development and commercialization, including the overall clinical development plan, publication planning, and studies.
• Represents Biometrics on one or more Dev Core Team or clinical sub team (as appropriate for the clinical program).
• Collaborates with Clinical Development, Medical Writing, and Regulatory Affairs project team members and consultants in the development of clinical study protocols, statistical analysis plans, and clinical study reports.
• Identifies appropriate, efficient experimental designs, defines analysis endpoints, develops randomization plans, and determines appropriate statistical methods of analysis for clinical studies.
• Represents Biostatistics in interactions with regulatory agencies.
• Reviews and approves clinical study database data validation specifications, data review plans, coding guidelines, and data transfer agreements.
• Prepares, reviews, and approves statistical analysis plans.
• Oversees and monitors CRO performance of statistical analyses and programming to ensure that timelines are met, resource issues are identified and resolved, and all applicable data and programming standards are adhered to.
• Provides biostatistical support to nonclinical, medical affairs, and commercial areas of the company as needed.
• Assists in the development of department standard operating procedures, statistical analysis plan and report templates, data standards, and selection and implementation of statistical software.
• Mentors junior members of the biostatistics team and supervises their work on an as-needed basis.
• Reviews, approves and implements new and innovative statistical methods for the analysis of clinical study data and adaptive study designs.
• Assumes a leadership role in clinical program(s), with the responsibility of ensuring that the statistical requirements are met for all projects in the program(s).
• Performs other duties as assigned.

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Principal