Kailera Therapeutics, Inc.
Senior Statistical Programming Analyst
Kailera Therapeutics, Inc., Waltham, Massachusetts, United States, 02254
Overview
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 a Senior Statistical Programming Analyst. 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 (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 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: Minimum of 4+ 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 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 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 $110,000 - $140,000 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. #LI-Hybrid Apply for this job indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Preferred Name LinkedIn Profile Please confirm your current state of residency * Select... Will you now or in the future require Visa sponsorship? * Select... If you do not currently reside in the Greater Boston or Greater San Diego areas, would you be willing to relocate to one of those areas to be able to work onsite or hybrid 2-3 days/week? Select...
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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 a Senior Statistical Programming Analyst. 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 (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 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: Minimum of 4+ 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 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 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 $110,000 - $140,000 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. #LI-Hybrid Apply for this job indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Preferred Name LinkedIn Profile Please confirm your current state of residency * Select... Will you now or in the future require Visa sponsorship? * Select... If you do not currently reside in the Greater Boston or Greater San Diego areas, would you be willing to relocate to one of those areas to be able to work onsite or hybrid 2-3 days/week? Select...
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