CrawlJobs Logo

Associate director, biostatistics

pfizer.de Logo

Pfizer

Location Icon

Location:
United States , Bothell

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

139100.00 - 225100.00 USD / Year

Job Description:

The Associate Director, Oncology Biometrics is a skilled biostatistician who can work independently as the study statistician for Phase 1-2 studies and under the direction of a Director of Biostatistics, or above, as the study statistician for Phase 3 studies. The person in this role is an individual contributor role who specializes in creating clinical study designs, performing data analysis, providing data interpretation, and contributing to clinical publication and regulatory submissions. Provides statistical input to study designs and can contribute to departmental or cross-functional initiatives to enhance business processes and improve efficiency.

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
  • Perform the analyses of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community by contributing to the clinical study reports, clinical publications, conference posters and presentations
  • Review and contribute to study and project timeline and provide high quality statistical deliverables in a timely manner
  • Provide statistical leadership in clinical study team setting
  • May independently present at department, project team, or Sr. Management meetings
  • May lead inter-department projects involving other contributors

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
  • Demonstrated ability to take on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm
  • Demonstrated ability to consistently achieve results, even under tough circumstances
  • Demonstrated ability to adapt approach and demeanor in real time to match the shifting demands of different situations
  • Demonstrated ability to build partnerships and work collaboratively with others to meet shared objectives
  • Demonstrated ability to make sense of complex, high quantity, and sometimes contradictory information to effectively solve problems
  • Demonstrated ability to plan and prioritize work to meet commitments aligned with organizational goals

Nice to have:

  • Oncology experience
  • Strong statistical research and simulation skills and experience
  • Breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
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

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Associate director, biostatistics

Associate Director Biostatistics

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN)...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate in Statistics/Biostatistics (or related subject with high statistical content) with at least 12+ years of post-graduate statistical experience in the pharmaceutical industry or medical research
  • Master’s degree in Statistics/Biostatistics (or related subject with high statistical content) with at least 16+ years of post-graduate statistical experience in the pharmaceutical industry or medical research
Job Responsibility
Job Responsibility
  • Provide sound statistical guidance to clinical development, reimbursement, and medical affairs
  • Oversee statistical contributions to protocols, randomization specifications, statistical analysis plans (SAPs), clinical study reports (CSRs), and key trial documents
  • Ensure alignment of study design and analysis with scientific rigor, regulatory requirements, and Amgen policies
  • Collaborate cross-functionally with global teams to deliver high-quality analyses, publications, and regulatory filings
  • Contribute to innovative trial designs, advanced methodologies, and process improvement initiatives
  • Execute biostatistical strategies across the product lifecycle, from early development through post-marketing
  • Provide consultancy and training to colleagues across R&D
  • Support governance of outsourced statistical activities, ensuring adherence to Amgen standards and regulatory compliance
  • Represent Biostatistics in cross-functional and external interactions (e.g., with regulatory agencies, investigators, or data monitoring committees)
  • Drive technology adoption leveraging AI capabilities to streamline statistician’s work
What we offer
What we offer
  • Vast opportunities to learn and develop within our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Read More
Arrow Right

Associate Director – Value Communication and Evidence Synthesis

As Associate Director – Value Communication & Evidence Synthesis, you will play ...
Location
Location
United Kingdom
Salary
Salary:
Not provided
bioscriptgroup.com Logo
Bioscript Group
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Postgraduate degree (MSc or PhD) in Health Economics, Public Health, Epidemiology, Biostatistics, or related life sciences discipline
  • 7+ years in market access, value communication, HEOR, or HTA consulting, with proven ability to lead complex, multi-disciplinary projects
  • Deep understanding of global HTA processes, payer evidence requirements, and market access dynamics
  • Demonstrated experience in evidence generation and synthesis, including systematic literature reviews, indirect treatment comparisons, and meta-analyses
  • Excellent analytical and writing skills, with the ability to distil complex data into actionable insights
  • Strong project and client management skills, with experience overseeing multiple projects and engaging senior stakeholders
  • Proven leadership and people management abilities, with a track record of mentoring and developing high-performing teams
  • Effective communicator with confident presentation skills and the ability to build trusted relationships with clients and colleagues
  • Experience contributing to business development, including proposal development and client pitches
Job Responsibility
Job Responsibility
  • Lead and deliver a diverse portfolio of projects across value communication, evidence synthesis, and HTA
  • Provide scientific and strategic oversight for the design, execution, and quality assurance of deliverables, including: global value dossiers, payer and reimbursement submissions, systematic and targeted literature reviews (SLRs, TLRs), evidence synthesis and meta-analyses (including ITCs and NMAs)
  • Translate complex data and analyses into clear, evidence-based narratives aligned with payer and stakeholder needs
  • Oversee multiple project teams, ensuring deliverables are completed on time, within budget, and to the highest quality standards
  • Manage project resourcing, timelines, and workload allocation to optimise team performance and impact
  • Line manage and mentor consultants and analysts, providing technical guidance and supporting professional growth
  • Foster a high-performance culture focused on collaboration, learning, and continuous improvement
  • Strengthen team capability in HTA, HEOR, and evidence synthesis methodologies
  • Collaborate across Valid Insight’s three core pillars—Strategy, Evidence Synthesis, and Value Communication—to deliver integrated, end-to-end market access solutions
  • Work with cross-functional teams within the Bioscript Group to leverage shared expertise and enhance project delivery
What we offer
What we offer
  • Competitive salary package
  • Flexible and remote working options
  • Generous annual leave policy which includes a winter shutdown
  • Birthday charity donation to a charity of your choice
  • Bonus Day off for community volunteering
  • Opportunities for professional development and career progression
  • Fulltime
Read More
Arrow Right

Associate Director, Biostatistics

We are seeking an Associate Director of Biostatistics. In this position you will...
Location
Location
United States
Salary
Salary:
195000.00 - 215000.00 USD / Year
apogeetherapeutics.com Logo
Apogee Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • PhD in statistics strongly preferred
  • MS in statistics, biostatistics or mathematics with depth of relevant experience in drug development statistical research will be considered
  • A minimum of 8 years’ experience in progressive and relevant clinical trial experience
  • Experience with phase 3 study and regulatory submission is preferred
  • Experience leading teams and working in a matrix organization
  • Ability to communicate and work directly with non-statisticians
  • Excellent communication with an ability to present to a variety of stakeholders
  • Experience managing CROs and other data vendors
  • Strong leader with a growth mindset
  • Ability to keep pace in a fast-moving organization and navigate ambiguity
Job Responsibility
Job Responsibility
  • Acting as the statistical lead for one or multiple projects
  • Providing technical leadership and statistical support on study design, project planning, conduct and execution of clinical studies, and scientific publications
  • Partnering closely with cross-functional teams
  • Providing expert biostatistics input on development plans, regulatory interactions, and study design
  • Authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL
  • Reviewing study randomization files, ADaM specs, CRF design, DMC charter
  • Analyzing and interpreting the clinical study results
  • Ensuring statistical integrity
  • Contributor on regulatory submissions
  • Provide expert statistical advice, methodological research and analysis of trial and epidemiological data
What we offer
What we offer
  • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
  • Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
  • Commitment to growing you professionally and providing access to resources to further your development
  • Apogee offers regular all team, in-person meetings to build relationships and problem solve
  • Fulltime
Read More
Arrow Right

Sr. Manager/Associate Director, Quantitative Science

The Quantitative Science team at BioMarin performs statistics and data science a...
Location
Location
United States , San Rafael
Salary
Salary:
151000.00 - 226400.00 USD / Year
biomarin.com Logo
BioMarin Pharmaceutical
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Associate Director, Statistical Programming

This is a critical role responsible for leading statistical programming activiti...
Location
Location
United States , Waltham
Salary
Salary:
160000.00 - 200000.00 USD / Year
kailera.com Logo
Kailera Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Associate Director, Statistical Programming

This is a critical role responsible for leading statistical programming activiti...
Location
Location
United States , Waltham
Salary
Salary:
160000.00 - 200000.00 USD / Year
kailera.com Logo
Kailera Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right
New

Vice president global head of statistics vcrd

Pfizer is seeking a Vice President, Global Head of Statistics to join our thrivi...
Location
Location
United States , Pearl River; Collegeville
Salary
Salary:
274000.00 - 426800.00 USD / Year
pfizer.de Logo
Pfizer
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Advanced degree in statistics, biostatistics, or related field required. PhD preferred.
  • 15+ years of experience in drug development
  • 5-10 years of experience in vaccine development
  • At least 5 years of managerial experience in drug development
  • Capability to provide statistical leadership to cross-functional teams and the ability to both communicate and influence the biostatical perspective to diverse audiences
  • Effective verbal and written communication skills relating to colleagues and associates both inside and outside the organization
  • A compelling and inspiring leadership style with a sharp scientific mind, who combines broad knowledge and understanding of biological systems and statistics. A world-class leader in his/her field.
  • Ability to perform sophisticated mathematical and statistical calculations, and to perform complex data analysis
  • Disaggregates complex problems to facilitate problem solving
  • Adept at distinguishing the relevance of information inputs to the decision-making process
Job Responsibility
Job Responsibility
  • Sets the vision and leadership for providing the highest level of data management, modeling, and statistical advice across the function to senior Vaccines Research and Development (VRD) leadership
  • Is accountable to lead the necessary stakeholders to plan, direct and coordinate a large and expanding portfolio of specialized and complex Vaccine Research and Development (VRD) projects spanning phase 1 through phase 4 clinical development
  • Must have the broadest knowledge of clinical data management and statistical analysis tools and interpret results from clinical, non-clinical, modelling and simulation, and epidemiologic studies
  • Is accountable to develop and roll out new initiatives and lead the VCRD Statistics group in strategic planning
  • Leads the activities of Senior Directors directing the statisticians and modelers in VCRD and at Functional Service Providers
  • Provides senior management review of protocols and CSRs, and is the senior representative to internal review committees, DMC-related company steering committees, etc.
  • Influences cross functional (TA) activities, in a consultative role, and provides the SVP of Clinical Research with more strategic advice as to the present and future direction for the VCRD Statistics group
  • Provides the highest level of strategic and statistic leadership to VRD leadership and the full vaccine portfolio
  • Lead and inspire the VRD statistics organization to provide the highest level of statistical and modeling support. Evaluates the material generated by supervised staff including senior director reports for validity, quality, and effectiveness of presentation and coaches them in preparation for regulatory and Key Opinion Leader interactions.
  • Provide senior management statistical review of key documents (protocols, CSRs, regulatory briefings)
What we offer
What we offer
  • eligibility for participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% 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 support available
  • Fulltime
Read More
Arrow Right
New

Butcher

The Schulson Collective is looking for a great butcher to join our restaurant.
Location
Location
United States , Philadelphia
Salary
Salary:
Not provided
michaelschulson.com Logo
Schulson Collective
Expiration Date
March 18, 2026
Flip Icon
Requirements
Requirements
  • Prior experience trimming, cutting and portioning all types of meats required
  • 2 years of experience
Read More
Arrow Right