Director, Biostatistics - Boston
1 day ago
Job description
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health.
Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence.As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
What You'll Do
As the Director of Biostatistics, you will lead statistical support for both early- and late-phase clinical studies, ensuring that statistical strategies and methodologies align with clinical development objectives and regulatory expectations.
In this critical role, you will lead the development, execution, and interpretation of statistical analyses, ensuring data quality, analysis integrity, and compliance with regulatory standards.
This role requires strong statistical and cross-functional leadership to influence clinical development strategy and decision-making, directly contributing to the success of the company's goals.
Required location:
Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).
ResponsibilitiesLead statistical efforts for early-to-late phase clinical studies, key regulatory, and submission activities
Provide statistical leadership in the development and execution of clinical development strategies by collaborating with cross-functional teams
Lead the development and the adoption of innovative statistical approaches (e.g., adaptive, seamless, Bayesian designs) to enhance trial efficiency, optimize resource utilization, and increase the probability of success
Ensure the accuracy, integrity, and consistency of statistical analyses across all clinical development programs, from Phase I through regulatory submissions and post-approval activities
Oversee CRO activities, ensuring quality deliverables, adherence to timelines, and efficient resource utilization
Required Qualifications
Advanced degree (PhD/MS) in Biostatistics or Statistics
PhD:
Minimum of 8+ years of relevant experience
MS:
Minimum of 10+ years of relevant experience
Successful experience in regulatory submissions, including NDAs, BLAs, and other filings
Strong leadership in statistical activities supporting clinical development programs
Participated in implementing innovative statistical methodologies to enhance clinical trial efficiency and effectiveness
Hands-on expertise with statistical software (e.g., SAS, R) and familiarity with CDISC standards
Strong problem-solving and strategic thinking skills, with the ability to translate complex statistical concepts into actionable insights for diverse stakeholders
Excellent communication and interpersonal skills, with the ability to influence decision-making and foster collaboration across functions
Extensive leadership experience in overseeing CRO activities
Education
PhD/MS in Biostatistics or Statistics
Salary Range
$204,000—$245,000 USD
For Full Time Roles:
This range represents the company's good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown.
Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.
Equal Employment Opportunity InformationKailera Therapeutics, Inc.
is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
E-VerifyKailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
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