Kailera Therapeutics, Inc.
Director, Biostatistics
Kailera Therapeutics, Inc., Waltham, Massachusetts, United States, 02254
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 the statistical support for 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 or San Diego, CA (onsite or hybrid 2-3 days per week).
Responsibilities:
Lead statistical efforts for late‑phase clinical studies and submission activities
Lead integrated safety analysis
Provide statistical leadership in the development and execution of clinical development strategies by collaborating with cross‑functional teams
Lead the collaboration with medical, regulatory, pharmacovigilance, pharmacology, clinical operations, and other functions to ensure appropriate statistical methodologies and analysis plans are implemented across all clinical studies
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, with experience in ISS/ISE
Strong leadership in statistical activities supporting clinical development programs and late‑phase clinical trials
Participated in implementing innovative statistical methodologies to enhance clinical trial efficiency and effectiveness
Hands‑on expertise with statistical software (e.g., SAS, R, Python) 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
Preferred Qualifications:
Experience as program‑level safety statistics lead
Education:
Advanced degree (PhD/MS) in Biostatistics or Statistics
Benefits of Working at Kailera In addition to traditional benefits, we provide enhanced offerings designed to support the well‑being and financial security of our team members and their families.
Comprehensive health benefits and tax‑advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year‑end shutdown
Monthly wellness stipend
Generous401(k) match
Disability and life insurance
At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job‑related knowledge, skills, market factors, and experience.
Salary Range $175,000 - $230,000 USD
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Kailera 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.
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What You’ll Do: As the Director of Biostatistics, you will lead the statistical support for 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 or San Diego, CA (onsite or hybrid 2-3 days per week).
Responsibilities:
Lead statistical efforts for late‑phase clinical studies and submission activities
Lead integrated safety analysis
Provide statistical leadership in the development and execution of clinical development strategies by collaborating with cross‑functional teams
Lead the collaboration with medical, regulatory, pharmacovigilance, pharmacology, clinical operations, and other functions to ensure appropriate statistical methodologies and analysis plans are implemented across all clinical studies
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, with experience in ISS/ISE
Strong leadership in statistical activities supporting clinical development programs and late‑phase clinical trials
Participated in implementing innovative statistical methodologies to enhance clinical trial efficiency and effectiveness
Hands‑on expertise with statistical software (e.g., SAS, R, Python) 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
Preferred Qualifications:
Experience as program‑level safety statistics lead
Education:
Advanced degree (PhD/MS) in Biostatistics or Statistics
Benefits of Working at Kailera In addition to traditional benefits, we provide enhanced offerings designed to support the well‑being and financial security of our team members and their families.
Comprehensive health benefits and tax‑advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year‑end shutdown
Monthly wellness stipend
Generous401(k) match
Disability and life insurance
At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job‑related knowledge, skills, market factors, and experience.
Salary Range $175,000 - $230,000 USD
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Kailera 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-Verify Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
#J-18808-Ljbffr