Senior Manager, Statistical Programming

Kailera is seeking an experienced Senior Manager of Statistical Programming to execute statistical programming activities for clinical trials, regulatory submissions, and other key initiatives. This role involves developing and reviewing programming specifications, validating SAS programs, leading integrated safety database development, and overseeing statistical vendors to ensure high-quality deliverables. The position supports Kailera's mission to advance novel therapies for obesity and related conditions.

Must Have

• Independently develop and review programming specifications
• Develop, validate, and oversee SAS programs for clinical study reports and ad hoc analysis
• Lead the development and QC of integrated safety database
• Direct and coordinate statistical vendors’ activities
• Conduct independent validation and quality checks of statistical programming deliverables from vendors
• Minimum of 5+ years of relevant experience in clinical development programming
• Experience in regulatory submissions, including NDAs, BLAs, and other filings
• In-depth understanding of CDISC standards

Good to Have

• A background in cardiometabolic diseases or related therapeutic areas

Perks & Benefits

• Comprehensive health benefits and tax-advantaged savings accounts
• Flexible time off
• 13 paid holidays
• Companywide year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Disability and life insurance

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 experienced programmers to join us as Senior Manager of Statistical Programming. This is a critical role responsible for executing 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 or San Diego, CA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).

Responsibilities:

• Independently develop and review programming specifications
• Develop, validate, and oversee SAS programs for clinical study reports, ad hoc analysis, and integrated safety summary analysis
• Lead the development and QC of integrated safety database from data specification development to dataset creation/QC
• Direct and coordinate statistical vendors’ activities to ensure high-quality deliverables: aCRF, data specification and dataset for SDTM and ADaM, mock shell and TFLs
• Conduct independent validation and quality checks of statistical programming deliverables from vendors
• Participate in the strategic development and QC of integrated safety analysis: data specifications, datasets and TFL outputs
• Communicate proactively and effectively around issues and risks, and contribute to its remediation

Required Qualifications:

• Minimum of 5+ years of relevant experience
• Proven hands-on experience in programming for clinical development with a strong preference for late-phase clinical trial support
• Experience in overseeing vendors, including reviewing data specifications, as well as independent validation of datasets, TFLs, and other statistical deliverables
• Experience in regulatory submissions, including NDAs, BLAs, and other filings, with experience in ISS/ISE highly desirable
• In-depth understanding of CDISC standards
• Good communication and collaboration skills in a cross-functional team environment

Preferred Qualifications:

• A background in cardiometabolic diseases or related therapeutic areas is preferred

Education:

• MS in Biostatistics, Statistics, or a related field

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

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

$136,000 - $170,000 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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