Manager, Statistical Programming

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 a 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.

Preferred location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).

Responsibilities:

• Develop, validate, and maintain SAS programs for clinical study reports, ad hoc analysis, and integrated safety summary analysis.
• Participate in the development and QC of integrated safety database from data specification development to dataset creation/QC.
• Oversee 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 development and QC of integrated safety analysis: data specifications, datasets and TFL outputs
• Manage multiple projects simultaneously, ensuring tasks are prioritized effectively to meet deadlines.
• Collaborate closely with Biostatisticians and cross-functional study teams to deliver results with speed and quality.
• Communicate proactively and effectively around issues and risks and contribute to its remediation

Required Qualifications:

• Proven hands-on experience in programming for clinical development with a strong preference for late-phase clinical trial support.
• Experience in overseeing vendors, including independent validation of datasets and 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.
• Familiarity with ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA).
• 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
• Minimum of 4+ years of relevant experience

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:

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