Kailera Therapeutics, Inc.

Associate Director, Statistical Programming

Waltham, Massachusetts · Director · Full-time

Sponsorship not specified$159k-$195kDetected 15 days ago

GCPStatisticsClinical TrialsFDA RegulatorySASResearchLeadershipBiostatistics

About the role

As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
This is a critical role responsible for leading statistical programming activities on the assigned disease area(s).
Actual pay may vary based on experience, skills, qualifications, location, and internal equity.

This role will support clinical trials, regulatory submissions, and other key initiatives.
Lead statistical programming efforts for clinical studies, including the development and review of programming specifications to ensure clarity, integrity, and compliance with internal and external standards
Lead the execution of ad-hoc and post-hoc analyses to support emerging clinical questions, publications, and internal decision-making
Collaborate closely with statisticians and cross-functional study teams to deliver results in a timely and accurate manner
Manage multiple projects simultaneously, ensuring tasks are prioritized effectively to meet deadlines
Proven hands-on experience in programming for clinical development, preferably in a leadership role, with a strong preference for late-phase clinical trial support

Experience in regulatory submissions, including NDAs, BLAs, and other filings, with experience in ISS/ISE highly desirable
Expertise in SAS programming and comprehensive knowledge of CDISC standards
Familiarity with ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA)

Background in cardiometabolic diseases or related therapeutic areas is preferred
Advanced degree (MS/PhD) in Biostatistics, Statistics, or a related field
MS: Minimum of 8+ years of relevant experience
PhD: Minimum of 6+ years of relevant experience
Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

$159,000 - $195,000 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.
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.
This range represents the company's good-faith estimate of the salary at the time of posting.

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 also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown.

We are seeking an experienced programmer to join us as Associate Director, Statistical Programming.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence.

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.

tive 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-rel

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