Associate Director, Statistical Programming Job at Kailera Therapeutics (Waltham)

Associate Director / Director, Medical Writing

Beam is seeking a highly talented and motivated AD/Director to join our growing ...

Location

United States , Cambridge

Salary:

180000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree required
MS, PharmD, or PhD preferred in a life science or health discipline
12+ years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
Demonstrated understanding of clinical regulatory documents (ie, protocol, IB, CSR, summaries for product filing, etc.) and experience as a lead author with such documents
Excellent communication skills, both oral and written
Ability to build strong relationships and work collaboratively across functions
Effective organizational and meeting skills and attention to detail
Experience with workflow management within standard document management systems
Ability to come onsite when needed such as for important meetings and team/company functions

Job Responsibility

Act as lead writer for clinical regulatory documents for the hematology program
Plan and lead the development of clinical study documents, working with cross-functional colleagues
Work closely with the regulatory team and other writers on regulatory document submissions
Assist with developing and maintaining medical writing process documents
Assist with evaluation and interpretation of the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, and scientific rigor
Contribute to statistical output plans concerning organization and table layout for specific documents
Project management, strategic design, planning, team input, and reviews
Opportunities for management/mentorship of other writers

Fulltime

Associate Director, Statistical Programming

This is a critical role responsible for leading statistical programming activiti...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

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
Advanced degree (MS/PhD) in Biostatistics, Statistics, or a related field

Job Responsibility

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

What we offer

Comprehensive health coverage
Flexible time off
Paid holidays
Year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Tuition reimbursement
Commuter benefits
Disability and life insurance
Annual bonus opportunities

Fulltime

Sr. Manager/Associate Director, Quantitative Science

The Quantitative Science team at BioMarin performs statistics and data science a...

Location

United States , San Rafael

Salary:

151000.00 - 226400.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

M.S. in Biostatistics, Statistics, Data Science, or similar field required
Ph.D. in Biostatistics, Statistics, Data Science, or similar field preferred
Minimum of 5 (PhD) or 7 (Master’s) years of experience in pharmaceutical and/or biotech industry for associate director
Minimum of 2 (PhD) or 4 (Master’s) years of experience in pharmaceutical and/or biotech industry for senior manager
Broad subject matter expertise in statistics and data science with hands-on experience in application in diverse areas
Proficiency in statistics, advanced data science, and programming
Exceptional communication/interpersonal skills

Job Responsibility

Perform statistical experimental design, analysis, interpretation, and reporting
Estimate sample size and aid in study design including conducting simulations
Conceptualize solutions to unique challenges and develop analysis methods and analysis programs accordingly
Explore and develop the use of artificial intelligence (AI) and machine learning (ML)
Write statistical analysis reports and give presentations
Develop statistical applications that enable researchers to analyze repetitive experiments
Conduct outreach to internal functions, establishing collaborations and providing education to identify opportunities to apply statistics and data science that positively impact the business
Provide guidance and direction to junior staff on the team

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Operations and Maintenance Supervisor

Supervises and directs mechanics and craft/trade shop activities. Implements the...

Location

United States , Winston Salem

Salary:

38.20 - 57.30 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

High School Diploma or GED required
Associate's degree preferred or continued education in technical or academic field
5 years supervisory experience, preferably in a hospital environment

Job Responsibility

Supervises and directs mechanics and craft/trade shop activities
Implements the maintenance program to accomplish departmental goals, objectives and standards of work performance within multiple buildings, structures and associated property
Develops, implements and directs a preventive and corrective maintenance program to ensure efficient operation at the facilities within the designated area of responsibility
Plans, develops and participates in ongoing departmental training and orientation programs in the repair and maintenance of equipment
evaluates the effectiveness of all programs and adjusts or modifies as necessary
Provides for the inventory and the storage of materials, parts and equipment
completes material requisitions and maintains adequate, conservative supply levels
selects and coordinates all maintenance service contractors
Insures that contractual provisions and schedules are met
communicates schedule changes and identifies problems to the appropriate responsible personnel

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program
Opportunity for annual increases based on performance
Premium pay such as shift, on call, and more based on a teammate's job
Incentive pay for select positions

Fulltime

Operations and Maintenance Supervisor

Supervises and directs mechanics and craft/trade shop activities. Implements the...

Location

United States , Winston Salem

Salary:

38.20 - 57.30 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

High School Diploma or GED required
Associate's degree preferred or continued education in technical or academic field
5 years supervisory experience, preferably in a hospital environment

Job Responsibility

Supervises and directs mechanics and craft/trade shop activities
Implements the maintenance program to accomplish departmental goals, objectives and standards of work performance within multiple buildings, structures and associated property
Develops, implements and directs a preventive and corrective maintenance program to ensure efficient operation at the facilities within the designated area of responsibility
Plans, develops and participates in ongoing departmental training and orientation programs in the repair and maintenance of equipment
evaluates the effectiveness of all programs and adjusts or modifies as necessary
Provides for the inventory and the storage of materials, parts and equipment
completes material requisitions and maintains adequate, conservative supply levels
selects and coordinates all maintenance service contractors
Insures that contractual provisions and schedules are met
communicates schedule changes and identifies problems to the appropriate responsible personnel

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

Recruiting Manager, Research Staff Services

Reporting to the Director, Research Staff Services (RSS), and working collaborat...

Location

United States , Boston

Salary:

75000.00 - 82000.00 USD / Year

HBS

Expiration Date

Until further notice

Requirements

Bachelor’s degree or equivalent work experience required
Minimum of 5 years’ relevant work experience required
Experience working in a research, academic, or non-profit environment
Demonstrated strong written and verbal communication skills
Proven ability to use technology effectively including proficiency in Word, Excel, and PowerPoint
Experience or interest in human resources
Experience working with applicant tracking systems
Professionalism, experience with and commitment to providing excellent service both within a team and on an individual basis
Sound judgment and critical thinking abilities
Excellent time management and organizational skills, including the ability to manage and prioritize multiple priorities

Job Responsibility

Develops, implements, and manages a recruitment strategy and process to identify and hire qualified candidates for researcher roles
Oversees recruiting operations for the Division of Research and Faculty Development (DRFD), coordinating recruitment activities across 10 teams
Directs end-to-end hiring for a variety of research support-focused roles, from position planning through onboarding
Facilitates the recruitment process for faculty supervisors and candidates to ensure excellent customer service
Maintains a pipeline of prospective candidates
Utilizes LinkedIn Recruiter account and various job portals to post and amplify job postings and to source candidates
Plans and executes a robust college recruitment program, including a strategy to attract under-represented minorities
Works collaboratively with RSS team members on temporary research appointments and with Human Resources and the Financial Office on all issues regarding research staff appointments and payrolls
Maintains and updates employment data and reviews and assesses the effectiveness of the recruitment experience and process
Establishes close working relationships with various departments including HBS Human Resources and the HBS Financial office

What we offer

Generous paid time off including parental leave
Medical, dental, and vision health insurance coverage starting on day one
Retirement plans with university contributions
Wellbeing and mental health resources
Support for families and caregivers
Professional development opportunities including tuition assistance and reimbursement
Commuter benefits, discounts and campus perks

Fulltime

Department Assistant Senior - Radiology Admin

An associate who provides administrative/secretarial support for their assigned ...

Location

United States , Texarkana

Salary:

Not provided

CHRISTUS Health

Expiration Date

Until further notice

Requirements

High school diploma or equivalent required
Associate’s preferred
Secretarial and computer experience including Microsoft Office (Word, Excel, Power Point) experience required
One or more years clerical experience, preferably in hospitals, or an equivalent combination of training

Job Responsibility

Demonstrates effective computer skills and effective use of programs including Infor, EPIC, Microsoft Word, Excel, and PowerPoint, and the CHRISTUS intranet
Performs assigned department maintenance duties
Maintains associate attendance records and reports identified problems/issues to department director
Assures Infor Timekeeping is maintained daily to reflect changes in schedules
Monitors email messages and posts important communications for other associates
Maintains competencies to provide relief for surgery scheduling clerk and data specialist as needed
Assists department director and team leaders in the maintenance of physician preferences, policies and procedures, letters and memoranda, reports, and other special projects as needed
Assimilates and analyzes monthly statistical data from Meditech to Excel
Performs other duties as assigned

Parttime

Business Director

As a Business Director at Capital One, you will apply your strategic and analyti...

Location

United States , Plano

Salary:

209500.00 - 239100.00 USD / Year

Capital One

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in any quantitative field (Business, Math, Economics, Finance, Statistics, Science, Engineering)
At least 7 years of experience in analysis
Master’s Degree
2+ years of experience in financial services
1+ year of experience in consulting
3+ years of experience in people management

Job Responsibility

Strategic leadership: Develop business strategies that will drive growth, profitability, and competitive success for Capital One in the face of shifting consumer and regulatory demands
Leadership: May manage and develop multiple analysts. Coaching and mentoring associates with a goal of developing and retaining talent at Capital One
Product: Develop and implement new product and pricing strategies for various lending products
lead product level data modeling/analytics
Marketing: Lead direct-to-consumer marketing efforts for select products, and strategic intent for products distributed through the retail channel. Build targeted insights to inform the design and development of new customer experiences, as well as breakthrough technology and concepts designed to deliver on new go-to-market strategies
Credit Risk: Drive step-change improvements in credit performance by connecting drivers of future consumer credit trends to historical behavior, creating risk models, and testing hypotheses using rigorous monitoring and analysis
Execution: Manage and sequence delivery of business intent, build business requirements and execute against the product strategy. Oversee multiple projects and programs concurrently
Partnership: Work closely with colleagues across Capital One including: IT, Sales, Operations, Finance and others to drive improvement in quality, volume, service, and profitability

What we offer

comprehensive, competitive, and inclusive set of health, financial and other benefits that support your total well-being
performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)

Fulltime

Associate Director, Statistical Programming

Kailera Therapeutics

Location:
United States , Waltham

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 03, 2026

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