Principal Biostatistician-San Diego based preferred

$128,200 - $185,900/Yr

Neurocrine Biosciences - San Diego, CA

Full-time - Mid Level

San Diego, CA

Chemical Manufacturing

About the position

Serves as the overall statistical lead on one or more clinical programs and will provide statistical input in design, analysis, and reporting of clinical studies to expedite conduct and evaluation of clinical trials and basic research. Leads statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Interacts with clinical investigators to determine protocol design. Evaluates databases and statistical analysis programs and interacts with computer groups to determine hardware/software compatibility.

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 subteam (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
• 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
• Works closely with statistical programmers to ensure that statistical methods are implemented correctly in statistical programs and collaborates with programmers in developing formats and specifications for summary tables, figures, and listings
• 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, including consulting and statistical analysis
• Assists in the development of department standard operating procedures and statistical analysis plan and report templates, data standards, and selection and implementation of statistical software

Requirements

• Master's degree in statistics or biostatistics, or a related discipline and 4+ years of experience in 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.
• Significant experience working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets.
• Proven interaction directly with regulatory authorities highly desirable.
• OR PhD in statistics or biostatistics, or a related discipline preferred and 2+ years of related experience.
• Demonstrated ability to provide statistical leadership and strategic input regarding the overall drug development plan and commercialization activities.
• Strong organizational skills and proven ability to effectively lead a project to successful completion.
• Significant expertise in the design, analysis, and reporting of clinical studies.
• 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.
• Expertise in interacting directly with regulatory authorities highly desirable.
• Maintains expertise in state-of-the-art data manipulation and statistical analyses.
• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines.
• Works to improve tools and processes within functional area.
• Developing reputation inside the company as it relates to area of expertise.
• Ability to work as part of and lead multiple teams.
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams.
• Excellent computer skills.
• Excellent communications, problem-solving, analytical thinking skills.
• Sees broader picture, impact on multiple departments/divisions.
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Excellent project management skills.

Benefits

• Retirement savings plan (with company match)
• Paid vacation
• Holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental and vision coverage
• Annual bonus with a target of 30% of the earned base salary
• Eligibility to participate in equity based long term incentive program