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Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. Summary: The Senior Director of Biostatistics acts as the statistical indication lead, providing strategic oversight for clinical development programs across one or multiple therapeutic areas. The Senior Director serves as the functional Biostatistics Therapeutic Area Lead and has direct leadership and accountability for biostatisticians aligned to the assigned therapeutic area.
The role is accountable for the scientific rigor, strategic direction, and operational excellence of all biostatistics activities across assigned programs. The Senior Director sets and drives the therapeutic area strategy in alignment with clinical and regulatory objectives, ensuring high-quality design, analysis, interpretation, and reporting of clinical trial data. The role is accountable for the biostatistics components of regulatory submissions, including briefing documents, responses to agency questions, and NDA/BLA/MAA filings.
This leader manages and develops a team of biostatisticians, including organizational design, resource planning, performance management, and budget oversight. The Senior Director also contributes to the biometrics strategy by advancing standards, methodologies, systems, and innovation across programs
Work Location: Hybrid Based Waltham, MA
Roles and Responsibilities:
- Provide strategic statistical leadership across assigned therapeutic areas, ensuring scientifically sound and operationally efficient execution of clinical development programs
- Lead and align biostatisticians supporting the assigned therapeutic area, establishing priorities, ensuring consistent scientific standards, and driving execution across programs
- Develop and implement organizational and staffing strategies to support portfolio needs and ensure high quality and on time completion of all deliverables
- Contributes to clinical development plans, regulatory strategies, and life cycle planning to optimize program success
- Serve as the senior statistical advisor to cross-fuctional leadership and senior management
- Represent Biostatistics in regulatory interactions, corporate partnerships, and CRO oversight
- Lead, mentor, and develop Biostatistics staff, fostering a culture of scientific rigor, accountability, and continuous improvement
- Advance departmental standards, governance, and innovative statistical methodologies across programs
- Partner cross-functionally with Clinical Development, Clinical Pharmacology, Regulatory, Data Management, and other functions to ensure aligned development strategies
Qualifications:
- PhD in Statistics, Biostatistics or Mathematics with a minimum of 10 years (minimum 15 years for master's degree) of post-graduate experience in pharmaceutical clinical development
- Deep expertise in statistical principles, clinical trial methodology, and regulatory expectations
- Extensive experience in supporting global regulatory submissions and agency interactions
- Demonstrated ability to develop innovative and practical statistical solutions to complex development challenges
- Comprehensive understanding of the clinical development lifecycle and the strategic role of biostatistics
- Strong effective communication skills with the ability to translate complex statistical concepts into clear business implications
- Proven ability to manage multiple complex projects and shifting priorities in a fast paced environment
- Demonstrated leadership in strategic planning, organizational design, conflict resolution, and cross-functional collaboration
- Strong people leadership skills with track record of building high performing teams and developing future leaders
Travel Requirements: Education: Pay Information: Base salary for this role will consider multiple factors, including but not limited to, candidate qualifications, relevant expertise, specialized skills, and industry experience in complement-targeted therapies. The targeted base salary range for this position is $238,000-$357,000. This range represents the base salary only and reflects Apellis' commitment to competitive compensation within the biopharmaceutical industry. The final salary offered may vary based on individual qualifications, business needs, and current market conditions.
Work Arrangement: Benefits and Perks:
Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit https://apellis.com/careers/benefits/ to learn more.
Company Background:
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit http://apellis.comor follow us on LinkedIn andX. EEO Statement:
Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law. For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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