Neurocrine Biosciences · 17 hours ago
Associate Biostats Director, Osavampator VMAT
San Diego, CA
Full-time
Onsite
Director/Executive
$174K/yr - $237K/yr
8+ years expNeurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients. The Associate Biostats Director serves as the overall statistical lead on multiple clinical programs, providing statistical input in design, analysis, and reporting of clinical studies.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Oversees contract biostatisticians to support the analysis and reporting of data from clinical studies for clinical development programs
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 report
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
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
Qualification
Required
Master's degree in statistics, biostatistics or related discipline AND 11+ 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 8+ years of similar experience as noted above
Considered an expert within the company and may have external presence in area of expertise
Applies in-depth 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
Sees broader picture and longer-term impact on division/company
Excellent leadership, coaching and development skills
Strong negotiation and influencing skills
Excellent communication, problem-solving, analytical thinking skills
Excellent computer skills
Excellent organizational and time management skills with the ability to work independently and in a team environment to meet established deadlines
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 multiple projects to successful completion
Advanced knowledge of SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data
Solid 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
Benefits
Annual bonus with a target of 30% of the earned base salary
Eligibility to participate in our equity based long term incentive program
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
Company
Neurocrine Biosciences
Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.
1001-5000 employees
H1B Sponsorship
Neurocrine Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (9)
2023 (8)
2022 (2)
2021 (5)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$260MKey Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO
Leadership Team
Matt Abernethy
Chief Financial Officer
D
Dimitri Grigoriadis
VP, Research
Recent News
BioWorld Financial Watch
2026-01-16
Company data provided by crunchbase