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

Associate Director, Breast Oncology Statistical Program

The Statistician in this role will have the title Associate Director of the Brea...

Location

United States , Boston

Salary:

95000.00 - 125100.00 USD / Year

Dana-Farber Cancer Institute

Expiration Date

Until further notice

Requirements

PhD degree in Statistics or Biostatistics and six years of experience required OR Master’s degree in Statistics or Biostatistics and ten years of experience
Experience in oncology and the design and analysis of clinical trials
Knowledge of UNIX/Linux and statistical software such as R or SAS
Expert at statistical methodology, and the use of statistical software, coding, data analysis and effective presentation of results
Comfortable with the statistical literature and able to implement state-of-the-art analytic techniques
Able to construct and implement complex study designs
Understands the nuances of data wrangling and has the ability to use sound principles of reproducible research methods
Adept at performing complex analysis methods and assessing underlying assumptions
Able to lead research teams and/or large projects
Independently discuss and present complex research designs and results to clinical collaborators

Job Responsibility

Routinely directs and supervises data analytic activities of more junior statisticians and/or leads complex projects
Trains, mentors and oversees the design activities of more junior statistical staff
Acts as a key participant in the articulation of the collaborative vision, working with program leaders and clinical research directors on scientific program direction and research portfolio
Independently represents the department on DF/HCC and DFCI committees, including but not limited to Scientific Review Committees (SRC) and Institutional Review Board (IRB)
May direct and/or advise junior statisticians in working with investigators to prepare scientific manuscripts
Expertise in consulting with investigators on all aspects of grant submissions
Work with the grants manager on all administrative aspects, including budget
Advises on the need for more diversified responsibilities, both for themselves and for more junior statisticians who they may supervise
responsible for coordinating statisticians and assuring that investigators are aware of the direct path to statistical assistance
Regularly mentor and advise more junior statisticians in all aspects of their responsibilities and career development

Fulltime

Associate director, biostatistics

The Associate Director, Oncology Biometrics is a skilled biostatistician who can...

Location

United States , Bothell; La Jolla; Cambridge; Groton; New York City

Salary:

139100.00 - 225100.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

Ph.D. in Statistics, Biostatistics or a related field with 5+ years of experience, or a master’s degree in Statistics, Biostatistics or related field with 7+ years of experience in clinical trials
Demonstrated high aptitude in FDA/EMA and other regulations
Demonstrated high aptitude in ICH GCP guidelines
Demonstrated high aptitude in Drug development process
Demonstrated high aptitude in CDISC standards and implementation guides
Demonstrated high aptitude in Statistical methods and applications to clinical trial design and data analysis
Demonstrated high aptitude in Programming skills in R and/or SAS
Demonstrated high aptitude in Company SOPs and business practices
Demonstrated ability to develop and deliver multi-mode communications
Demonstrated ability to manage multiple projects

Job Responsibility

Serve as a study statistician for assigned clinical studies related to one or more clinical programs
Provide statistically sound experimental design and data analysis strategies to meet project objectives with high quality in a timely manner
Provide statistical inputs on clinical development plans
Contribute to the development of clinical study protocols and author the statistical sections
Develop statistical analysis plans and work with programming to create table, listing and figure shells for clinical trials or ad-hoc analyses
Develop study randomization specification and verification documents as necessary
Perform sample size calculations and assess trial design operating characteristics under various assumptions
Review CRFs and edit checks and participate in UAT of different systems
Review dataset programming specifications, key derived variables, and statistical deliverables
Independently derive from source data key efficacy variables and analyses

What we offer

Participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

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

Head Athletic Trainer

This role is a leadership position in the Orthopedic Department's Athletic Train...

Location

United States of America , Rochester

Salary:

68285.00 - 88771.00 USD / Year

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's, Masters or Doctoral degree in Athletic Training, Exercise Physiology, or Bachelor's in a related field with internship route certification in Athletic Training or Certification as a Certified Strength and Conditioning specialist from the National Strength and Conditioning Association (NSCA)
National Athletic Trainers' Association Board of Certification NATABOC certification as an Athletic Trainer
New York State licensure
Requires employee to maintain all requirements required by Strong Memorial Hospital / Strong Health as a condition of employment, including but not limited to completion of annual health update, completion of annual mandatory in-service, and performance requirements
5 years of progressive supervision / athletic training related work experience in a clinic or college setting preferred
Cardiopulmonary Resuscitation, AED, and First Aid Training through the American Red Cross or American Heart Association

Job Responsibility

Directs all aspects of assigned clinical and performance program(s)
Establishes programmatic business relationships and maintain relationships with area Physicians and athletic professionals such as athletic teams, athletic organizations, colleges, etc. to help grow assigned program(s) based on strategic initiatives
Coordinates with other leaders who provide support personnel performing clinical rehabilitation, outreach athletic training, or performance coaching which interface with assigned programs(s)
Manages staff, including personnel decisions such as hiring/firing and performance management
Develops training and competency/skill assessment of staff required to perform the services of the assigned program(s)
Develops and maintains clinical staff schedules, including management of time-off requests, taking into account operational and program specific staffing needs as well as maximizing staff effectiveness and productivity
Develops programmatic and operational statistics for reporting to the Chief of Sports Rehabilitation and Administration
Designs and implements solutions to meet program goals and objectives
Performs, tracks, and audits departmental billing for assigned FAO(s) associated with program
Develops and modifies individualized programs for patient or client treatment working from physician's general or specific order(s)

Fulltime

Associate Director, Clinical Data Manager

Associate Director, Clinical Data Manager (Sponsor Dedicated). ICON plc is a wor...

Location

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in Data Science, Statistics, Bioinformatics, or a related field
Experience in all aspects of Data Management related clinical study planning and execution, and in executing the complete range of clinical study activities, from concept sheet through final study report and archiving
Proven experience as Clinical Data Manager in the pharmaceutical/biotechnology industry, equivalent to at least 10 years
Substantial project management experience
Strong leadership competencies and influencing skills
Effective oral and written communication skills
Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams
Growing expertise in drug development, including some knowledge of interfaces and interdependencies of clinical development with other functions (e.g., nonclinical & pharmaceutical development, regulatory, commercial/marketing)
Successful completion of multiple studies from beginning to end providing a full scope of DM experience

Job Responsibility

Leading Data Management including centralized monitoring related activities within a complete clinical development program (Phase I-IV, Accountable and Project Leadership) for global or regional trials and/or programs with different complexity
Serving as the escalation point, work with CRO data managers, vendors, internal team members for resolution
Ensures and tracks data quality of clinical database/deliverables (incl. CRF and non-CRF data) and submission readiness of the clinical data management deliverables and data packages (e.g. CDISC)
Project management of all clinical data management related deliverables including operationalization by steering internal and external experts and specialist. Ensuring adherence to planned time, cost and quality
Execution of the clinical data collection strategy in accordance to Sponsor Standards
Accountable for oversight of CROs in the execution of Phase I – IV clinical trial(s)
Represents Data Management within the Global Trial Team and serves as the key Global Development Operations point of contact for the DM related tasks in a trial/project/program
Key contributor to the development of reports and communicating to relevant line management and Clinical Operations Teams
Drives, leads and manages the successful execution, oversight and approval of all DM related clinical trial documents and operational plans (e.g. Data Management Plan) of clinical trials using strong project management, leadership, and organizational skills
Ensures strong oversight, review and delivery of trial/project DM related CAPAs in order to meet corporate compliance standards and timelines

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

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

Associate Director, Statistical Programming

Kailera Therapeutics

Location:
United States , Waltham

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 15, 2026

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