Principal Biostatistician
Neurocrine Biosciences
5 hours ago
Remote friendly (San Diego, CA)
United States
$130,800 - $179,000 USD yearly
Clinical Research and Development
About The Role
- Serve as overall statistical lead on one or more clinical programs; provide statistical input in design, analysis, and reporting of clinical studies to expedite conduct and evaluation of clinical trials and basic research.
- Lead statistical analysis and develop tracking systems to determine clinical trial efficiency.
- Interact with clinical investigators to determine protocol design.
- Evaluate databases and statistical analysis programs and work with computer groups to determine hardware/software compatibility.
Your Contributions
- Provide statistical leadership and strategic input to the Dev Core Team (clinical development plan, publication planning, and studies).
- Represent Biometrics on Dev Core Team and/or clinical subteams.
- Collaborate with Clinical Development, Medical Writing, and Regulatory Affairs on clinical study protocols, statistical analysis plans, and clinical study reports.
- Identify experimental designs; define analysis endpoints; develop randomization plans; determine statistical methods of analysis.
- Review/approve database data validation specifications, data review plans, coding guidelines, and data transfer agreements.
- Prepare/review/approve statistical analysis plans.
- Partner with statistical programmers to ensure correct implementation and develop specifications for summary tables, figures, and listings.
- Oversee/monitor CRO performance of statistical analyses and programming; ensure timelines, resolve resource issues, and adhere to data/programming standards.
- Provide biostatistical support to nonclinical, medical affairs, and commercial areas as needed.
- Assist with SOPs and templates; develop data standards; select and implement statistical software.
- Mentor/supervise junior biostatistics team members as needed.
- Research, develop, and implement new/innovative statistical methods for clinical study data and adaptive study designs.
- Lead clinical program(s) to ensure statistical requirements are met for all projects.
Requirements
- Master’s degree in statistics/biostatistics (or related) + 4+ years designing, analyzing, and reporting clinical studies; demonstrated SAS programming (SAS procedures for clinical analyses); significant CDISC/FDA standards experience for SDTM and ADaM dataset creation; regulatory authority interaction highly desirable.
- OR PhD in statistics/biostatistics (or related) preferred + 2+ years related experience.
Key Skills/Preferences
- Statistical leadership and strategic input for drug development and commercialization.
- Strong organizational skills; ability to lead projects to successful completion.
- Thorough knowledge of clinical study design, analysis, and reporting.
- Advanced knowledge of SAS programming and CDISC/FDA SDTM/ADaM.
- Thorough knowledge of regulatory guidelines for clinical study design, analysis, reporting, and submission.
- Ability to work as part of and lead multiple teams; leadership of lower levels/indirect teams.
- Excellent computer skills; strong communication, problem-solving, analytical thinking.
- Ability to manage multiple deadlines with accuracy/efficiency; excellent project management.
Benefits
- Annual base salary: $130,800.00–$179,000.00; annual bonus target 30% of earned base salary; eligibility for equity-based long-term incentive.
- Retirement savings plan (company match); paid vacation/holidays/personal days; paid caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).
Application Instructions
- Apply even if your experience/qualifications don’t exactly match the job description.
- Serve as overall statistical lead on one or more clinical programs; provide statistical input in design, analysis, and reporting of clinical studies to expedite conduct and evaluation of clinical trials and basic research.
- Lead statistical analysis and develop tracking systems to determine clinical trial efficiency.
- Interact with clinical investigators to determine protocol design.
- Evaluate databases and statistical analysis programs and work with computer groups to determine hardware/software compatibility.
Your Contributions
- Provide statistical leadership and strategic input to the Dev Core Team (clinical development plan, publication planning, and studies).
- Represent Biometrics on Dev Core Team and/or clinical subteams.
- Collaborate with Clinical Development, Medical Writing, and Regulatory Affairs on clinical study protocols, statistical analysis plans, and clinical study reports.
- Identify experimental designs; define analysis endpoints; develop randomization plans; determine statistical methods of analysis.
- Review/approve database data validation specifications, data review plans, coding guidelines, and data transfer agreements.
- Prepare/review/approve statistical analysis plans.
- Partner with statistical programmers to ensure correct implementation and develop specifications for summary tables, figures, and listings.
- Oversee/monitor CRO performance of statistical analyses and programming; ensure timelines, resolve resource issues, and adhere to data/programming standards.
- Provide biostatistical support to nonclinical, medical affairs, and commercial areas as needed.
- Assist with SOPs and templates; develop data standards; select and implement statistical software.
- Mentor/supervise junior biostatistics team members as needed.
- Research, develop, and implement new/innovative statistical methods for clinical study data and adaptive study designs.
- Lead clinical program(s) to ensure statistical requirements are met for all projects.
Requirements
- Master’s degree in statistics/biostatistics (or related) + 4+ years designing, analyzing, and reporting clinical studies; demonstrated SAS programming (SAS procedures for clinical analyses); significant CDISC/FDA standards experience for SDTM and ADaM dataset creation; regulatory authority interaction highly desirable.
- OR PhD in statistics/biostatistics (or related) preferred + 2+ years related experience.
Key Skills/Preferences
- Statistical leadership and strategic input for drug development and commercialization.
- Strong organizational skills; ability to lead projects to successful completion.
- Thorough knowledge of clinical study design, analysis, and reporting.
- Advanced knowledge of SAS programming and CDISC/FDA SDTM/ADaM.
- Thorough knowledge of regulatory guidelines for clinical study design, analysis, reporting, and submission.
- Ability to work as part of and lead multiple teams; leadership of lower levels/indirect teams.
- Excellent computer skills; strong communication, problem-solving, analytical thinking.
- Ability to manage multiple deadlines with accuracy/efficiency; excellent project management.
Benefits
- Annual base salary: $130,800.00–$179,000.00; annual bonus target 30% of earned base salary; eligibility for equity-based long-term incentive.
- Retirement savings plan (company match); paid vacation/holidays/personal days; paid caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).
Application Instructions
- Apply even if your experience/qualifications don’t exactly match the job description.