Executive Director, Biostatistics jobs in United States
cer-icon
Apply on Employer Site
company-logo

Bausch Health Companies Inc. · 8 hours ago

Executive Director, Biostatistics

Bausch Health Companies Inc. is a global diversified pharmaceutical company dedicated to improving health outcomes for patients. They are seeking an Executive Director, Biostatistics to lead the biostatistics function, shape global development programs, and influence regulatory strategy across the organization.

BiotechnologyHealth CareMedicalPharmaceutical
check
H1B Sponsor Likelynote

Responsibilities

Serve as the companys statistical authority and leader, accountable for statistical strategy, oversight, and execution across the full clinical development lifecycle
Provide immediate leadership for a high priority newly acquired Phase 3 asset, including study design, data strategy, and statistical oversight
Drive statistical leadership for all key programs, including IND-enabling work, multiple phase 2/3 trials, global regulatory submissions, and post-marketing requirements
Partner with clinical development leadership on clinical strategy, program risk assessment, and decision making at the highest levels
Lead the design, statistical modeling, and analysis planning for clinical trials with appropriate balance of innovation and regulatory rigor
Oversee and/or author development of key statistical documents, including Statistical Analysis Plans (SAPs), protocols, and regulatory components of global regulatory submissions
Oversee internal biostatistical resources and lead strategic outsourcing to ensure scalable support for a growing portfolio
Recruit, develop, and mentor a fit-for-purpose internal team, while effectively managing partnerships with CROs and statistical consultants
Lead interactions with global regulatory authorities from a statistical perspective, including preparing for and participating in agency meetings (eg, FDA, EMA, PDMA)
Anticipate and respond to statistical challenges in BD evaluations, portfolio expansion, and evolving regulatory guidance
Represent Biostatistics in governance forums, development leadership meetings and cross-functional initiatives

Qualification

Ph.D. in BiostatisticsClinical Biostatistics ExperienceStatistical LeadershipGlobal Regulatory SubmissionsStatistical MethodologiesCommunication SkillsCollaboration SkillsBusiness Development AssessmentsMatrix Organization Experience

Required

Ph.D. required. Biostatistics, Statistics discipline preferred
Minimum 15 years of experience in clinical biostatistics within biotech or pharma, including significant leadership in submissions, pivotal trials, and global regulatory interactions required
Demonstrated experience providing statistical leadership at the portfolio level across multiple therapeutic areas, preferably including gastroenterology, immunology, dermatology, or neuroscience
Strong record of contributions to global regulatory submissions (eg, INDs, NDAs, BLAs), including responsibility for briefing books, response documents, and participation in meetings with health authorities (eg, FDA, EMA)
Highly proficient in modern statistical methodologies and tools; hands-on ability when needed in a lean environment
Proven success in building and scaling statistical capabilities within high-growth or resource-constrained settings
Exceptional communication and collaboration skills, capable of influencing senior stakeholders, leading matrixed teams, and navigating ambiguity
Deep understanding of the role of biostatistics in shaping global clinical and regulatory strategy, not just execution
Thrive in a matrix and lean organization and comfort working across multiple stakeholders and geographies

Preferred

Experience in business development assessments and integration of statistical thinking into asset evaluations is a plus

Benefits

Comprehensive Medical (includes Prescription Drug)
Dental
Vision
Flexible Spending Accounts
401(k) with matching company contribution
Discretionary time off
Paid sick time
Tuition reimbursement
Parental leave
Short-term and long-term disability
Life insurance
Accidental death & dismemberment insurance
Paid holidays
Employee referral bonuses
Employee discounts

Company

Bausch Health Companies Inc.

twittertwittertwitter
company-logo
Bausch Health Companies Inc.

H1B Sponsorship

Bausch Health Companies Inc. 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 (8)
2024 (7)
2023 (4)
2022 (13)
2021 (4)
2020 (5)

Funding

Current Stage
Public Company
Total Funding
$7.4B
Key Investors
Kohlberg Kravis Roberts
2025-05-21Post Ipo Debt· $2.52B
2025-03-25Post Ipo Debt· $3.08B
2023-07-07Post Ipo Debt· $600M

Leadership Team

leader-logo
Thomas J. Appio
Chief Executive Officer
linkedin
leader-logo
Graham Jackson
SVP, Chief Quality Officer & Global Head Technical Operations
linkedin
Company data provided by crunchbase