Kailera Therapeutics, Inc.
Associate Director, Statistical Programming
Kailera Therapeutics, Inc., Waltham, Massachusetts, United States, 02254
Associate Director, Statistical Programming
Waltham, Massachusetts
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 We are seeking an experienced programmer to join us as Associate Director, Statistical Programming. This is a critical role responsible for leading statistical programming activities on the assigned disease area(s). This role will support clinical trials, regulatory submissions, and other key initiatives.
Required location:
Waltham, MA (hub-based, onsite 3-4 days per week)
Responsibilities
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
Oversee and coordinate activities with Contract Research Organizations (CROs), focusing on the implementation of CDISC standards, creation of SDTM, ADaM datasets, and TFLs, and ensuring high-quality deliverables
Conduct independent validation and quality checks of statistical programming deliverables from CROs
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
Required Qualifications
Minimum of 7+ years of relevant experience with MS, 5+ years of relevant experience with PhD
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)
Extensive experience overseeing CROs, including independent validation of datasets and statistical deliverables
Preferred Qualifications
Background in cardiometabolic diseases or related therapeutic areas is preferred
Education
Advanced degree (MS/PhD) in Biostatistics, Statistics, or a related field
MS:
Minimum of 7+ years of relevant experience
PhD:
Minimum of 5+ years of relevant experience
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
Generous 401(k) match
Disability and life insurance
Salary Range $160,000 - $200,000 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.
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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 We are seeking an experienced programmer to join us as Associate Director, Statistical Programming. This is a critical role responsible for leading statistical programming activities on the assigned disease area(s). This role will support clinical trials, regulatory submissions, and other key initiatives.
Required location:
Waltham, MA (hub-based, onsite 3-4 days per week)
Responsibilities
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
Oversee and coordinate activities with Contract Research Organizations (CROs), focusing on the implementation of CDISC standards, creation of SDTM, ADaM datasets, and TFLs, and ensuring high-quality deliverables
Conduct independent validation and quality checks of statistical programming deliverables from CROs
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
Required Qualifications
Minimum of 7+ years of relevant experience with MS, 5+ years of relevant experience with PhD
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)
Extensive experience overseeing CROs, including independent validation of datasets and statistical deliverables
Preferred Qualifications
Background in cardiometabolic diseases or related therapeutic areas is preferred
Education
Advanced degree (MS/PhD) in Biostatistics, Statistics, or a related field
MS:
Minimum of 7+ years of relevant experience
PhD:
Minimum of 5+ years of relevant experience
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
Generous 401(k) match
Disability and life insurance
Salary Range $160,000 - $200,000 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