Olema Oncology · 1 week ago
Senior Director, Biostatistics
Cambridge, MA
Full-time
Onsite
Director/Executive
$292K/yr - $308K/yr
10+ years expOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. As the Senior Director of Biostatistics, you will lead the statistical strategy and execution of a pivotal Phase 3 clinical trial, collaborating cross-functionally to ensure scientific rigor and regulatory alignment.
BiopharmaBiotechnologyHealth CareMedicalOncologyPharmaceutical
Hiring Manager
Michelle Knobel
Responsibilities
Lead the biostatistics strategy and execution for a pivotal Phase 3 trial and ISS/ISE, ensuring scientific rigor and global regulatory alignment
Apply innovative statistical methods to optimize study design, analysis strategies, and data interpretation
Develop and author key statistical documents
Lead statistical activities for regulatory submissions and prepare briefing materials for health authority interactions
Provide statistical input for CSRs, IBs, DSURs, and other study-level and submission documents
Oversee development of SDTM, ADaM, and TLF deliverables to ensure accuracy and compliance with regulatory and CDISC standards
Manage CRO statistical activities, including DMC deliverables, to ensure high-quality execution
Manage and mentor junior statisticians as applicable
Provide statistical leadership across multiple projects with overlapping timelines, as needed
Qualification
Required
Strong understanding of regulatory requirements, industry standards, and guidance documents
Broad and thorough knowledge of statistical principles and clinical trial methodology, with the ability to apply best practices in oncology study design and analysis
Comprehensive understanding of RECIST 1.1 guidelines
Expertise in CDISC standards, including SDTM and ADaM
Proficiency in SAS and/or R programming
Demonstrated ability to lead and successfully complete major programs and projects
Strong analytical, problem-solving, and communication skills
Experience interacting with regulatory agencies, including the FDA and international health authorities
10+ years of experience in the biotech or pharmaceutical industry, with a PhD in Statistics or Biostatistics
Minimum of 3 years direct leadership experience
Extensive experience in late-stage oncology drug development, including the design and execution of registrational Phase 3 studies
Proven experience in regulatory interactions, with a strong track record of NDA or sNDA submissions
Experience building a biostatistics strategy and execution of a global NDA submission (Phase 3, ISS, ISE)
Demonstrated ability to manage CROs in the conduct and analysis of clinical trials
Proven ability to represent Biostatistics effectively in multidisciplinary meetings
Strong history of effective collaboration across cross-functional teams
Strong leadership skills, including proactive strategic thinking, prioritization, adaptability, conflict resolution, and partnership-building
Deep statistical expertise and experience overseeing the statistical components of clinical trials
Ability to develop innovative and creative statistical and technical solutions to complex problems
Excellent verbal and written communication skills
Commitment to excellence and consistently delivering high-quality work
Self-motivated and enthusiastic, with the ability to quickly learn, identify core project challenges, and adapt to evolving requirements in a fast-paced environment
Possesses impeccable professional ethics, integrity, and judgment
Benefits
Equity
Bonus
Benefits
Competitive compensation and benefits package
Company
Olema Oncology
Olema Oncology is a preclinical biotechnology company that develops new drugs for the treatment and prevention of breast cancer.
51-200 employees
H1B Sponsorship
Olema Oncology 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 (4)
2024 (3)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$765.05MKey Investors
Paradigm BioCapital AdvisorsSilicon Valley BankVivo Capital
2025-11-20Post Ipo Equity· $190M
2024-12-02Post Ipo Equity· $250M
2023-09-05Post Ipo Equity· $130M
Leadership Team
Naseem Zojwalla
Chief Medical Officer
Shane Kovacs
Chief Operating and Financial Officer
Recent News
2026-01-13
2025-12-25
Company data provided by crunchbase