Statistics Director, Oncology Job at GSK (London)

Director, Oncology Clinical Pharmacology Modeling and Simulation

At GSK, we have bold ambitions for patients, aiming to positively impact the hea...

Location

United States , Collegeville; Waltham; Durham

Salary:

188100.00 - 313500.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

PhD in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) and experience in using modelling/simulation to solve practical problems in industry or academia. PharmD or Master's degree in the same disciplines with an additional 4 years of relevant experience may be considered
5+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling
and verifiable proficiency in pharmacometric tools NONMEM or R
3+ years of experience in planning, performing, and reporting model-based analysis of clinical data per industry and regulatory standards

Job Responsibility

Defining and executing model-based development strategies for oncology projects
Planning, conducting and reporting exposure-response analysis, simulation-based trial design and dose selection, and population PK modelling
Applying innovative methods such as drug-disease modeling, longitudinal exposure-response analysis, model-based meta-analysis, quantitative systems pharmacology and AI/ML informed analyses to enhance data use and trial efficiency
Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions
Write or review clinical pharmacology components of regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology, modelling and simulation contents)
Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline
Ability to interact with line and middle management, staff and external contacts on a functional, strategic and tactical level
Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation

Fulltime

Physician Director Oncology Data Science - Translational Science

Are you looking for an opportunity to lead a Translational Data Science team wit...

Location

United States , Collegeville, Pennsylvania

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

medical degree
Completion of a clinical residency program leading to board qualification or certification in internal medicine, pathology, pediatrics is required
10 years plus academic or industry experience in Computational Biology, Bioinformatics, or Translational/Clinical AI with focus on Oncology
5 years of leadership or matrix leadership experience in Computational Biology, Applied AI/ML, Cancer Biology or a related field

Job Responsibility

Lead and build a growing team of Translational Data Scientists to support and innovate the Oncology portfolio pipeline
Leverage your clinical training and experience to translate complex computational and molecular insights into clinically meaningful hypotheses, study designs, and biomarker strategies that directly inform patient care and oncology clinical development
Contribute scientific expertise and design to multiple drug discovery or development efforts across oncology
Act as a competent and recognized expert in developing and critiquing the scientific validity of research/development initiatives to drive the development and delivery of long-term scientific strategy in Oncology Genomics
Individually contribute with analyses and integration of complex cancer datasets. This includes analysis of histopathology imaging data, gene & protein expression (bulk + single cell + spatial), somatic mutations, copy number alterations, and structural variants
Apply statistical methods and AI/machine learning algorithms to identify patterns in data, predict drug response, and discover potential biomarkers. Critically evaluate results. Conduct survival analysis to assess the impact of various factors on patient outcomes
Lead the development and use of bioinformatics pipelines
Serve as a recognized leader in driving technological foresight within specific scientific function or directing content of programs
Lead and influence the outcome of multidisciplinary meetings including partners in therapeutic research units, translational and clinical development teams.
Communicate complex scientific findings clearly to both technical and non-technical audiences.

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Medical Director, Oncology

During the last five years, Parexel has participated in more than 1,000 Oncology...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Medically qualified based on successful completion of training at an accredited medical school
US or Canada Board-certified in Oncology with experience in adult or pediatric clinical patient care
Excellent interpersonal skills
Excellent time management skills
Excellent verbal and written medical communication skills
Excellent standard of written and spoken English
A flexible attitude with respect to work assignments and new learning
The ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
A willingness to work in a matrix environment and to value the importance of teamwork
The ability to travel 10% domestically and/or internationally as needed

Job Responsibility

Provide medical monitoring for assigned projects
Function as medical representative on the project team
Provide medical consultation as required or requested to client/sponsor or to other Parexel service groups
Assume the role of Senior Technical Lead in selected circumstances
Review all individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness
Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis, summarizing adverse experiences as required by FDA or the sponsor
Review data listings of safety data, including adverse experiences, laboratory data, and vital signs data, to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate
Review documents written by various Parexel divisions for safety issues
Review coding of adverse events and concomitant medications for accuracy and consistency
Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents

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

Director, Research Services, Oncology

As a Director, Research Services at ICON, you will be responsible for working wi...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Degree in a scientific/life sciences field
Pharm.D. or Ph.D. preferred
Minimum of 8 years of experience in oncology research or related field
Demonstrated experience leading clinical development programs in oncology (preferably late-stage)
Experience with global regulatory interactions and submissions (FDA, EMA, or other agencies)
Strong understanding of oncology clinical endpoints, trial design, and statistical considerations
Proven ability to work effectively in a cross-functional matrix environment and influence without direct authority
Track record of scientific publications and/or conference presentations
Excellent written and oral communication skills
Strong analytical and scientific writing skills

Job Responsibility

Development of protocols for clinical studies
Preparation of clinical development plans
Drafting of clinical scientific documents such as IND, IND amendments, Investigator’s Brochures, Annual Reports and other FDA submissions
Monitor, perform data review, and summarize safety and efficacy data in ongoing studies
Assist with study design for exploratory development
Lead the clinical matrix teams for assigned compounds
Represent exploratory development on project teams
Develop relationships with appropriate consultants
Write abstracts and present data at scientific meetings, both internally and externally
Serve as liaison to project teams, CROs and others

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

Senior Director, Clinical Development, Oncology

Moderna is seeking an experienced oncology drug developer lead Clinical Developm...

Location

United States , Cambridge, Massachusetts; Princeton, New Jersey

Salary:

210900.00 - 379200.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant hematology and/or oncology in an academic or hospital environment
Experience in oncology drug development demonstrated by at least 3 years in the biopharmaceutical industry
In exceptional cases, at least 5 years of experience as an early-phase clinical trialist in academia would be considered
Medical oncology and/or hematology fellowship training is preferred
Experience in oncology and/or hematology immunotherapeutics is preferred
Experience in conducting translationally rich oncology and/or hematology clinical trials is highly valued
Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
Outstanding verbal and written communication skills, in addition to excellent organizational skills
Understanding of the entire drug development process, including clinical and non-clinical study design and execution
Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules

Job Responsibility

Collaborate in the development and execution of the Clinical Development Plan (CDP) for assigned oncology assets
Integrates scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the Integrated Development Plan (IDP) and CDP
Generates data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe
Establishes expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP
Collaborate effectively with program counterparts in Translational Medicine, Pharmacometrics, Research, Biostatistics, Clinical Operations, Regulatory, Commercial, and other functional areas as needed
Contributes to and partners with the development of strategic initiatives, such as organizational initiatives within Clinical Development
Plays an active role in the technical and leadership development of Clinical Scientists
Employs visioning and strategic thinking to provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s)
Leads selected clinical development projects for products/franchise of compounds
Able to lead and influence across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver integrated clinical development strategy, which align to the business strategy and achieves mutual goals related to patient need

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
Eligible for an annual discretionary bonus, other incentive compensation, or equity award

Fulltime

Director, Clinical Research Scientist Oncology

Turn scientific insight into life-changing oncology therapies through clinical l...

Location

United States , Wilmington

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Degree in a scientific/life sciences field
Pharm.D. or Ph.D. preferred.
Minimum of 8 years of experience in oncology research or related field.
Demonstrated experience leading clinical development programs in oncology (preferably late-stage).
Experience with global regulatory interactions and submissions (FDA, EMA, or other agencies).
Strong understanding of oncology clinical endpoints, trial design, and statistical considerations.
Proven ability to work effectively in a cross-functional matrix environment and influence without direct authority.
Track record of scientific publications and/or conference presentations.
Excellent written and oral communication skills.
Strong analytical and scientific writing skills.

Job Responsibility

Collaborate with physicians, clinical scientists, and cross-functional teams to support oncology clinical development, focusing on protocol development and study start-up activities.
Development of protocols for clinical studies.
Preparation of clinical development plans.
Drafting of clinical scientific documents such as IND, IND amendments, Investigator's Brochures, Annual Reports and other FDA submissions.
Monitor, perform data review, and summarize safety and efficacy data in ongoing studies.
Assist with study design for exploratory development.
Lead the clinical matrix teams for assigned compounds.
Represent exploratory development on project teams.
Develop relationships with appropriate consultants.
Write abstracts and present data at scientific meetings, both internally and externally.

Fulltime

Associate Director, US Real-World Evidence and Health Outcomes – Oncology Pipeline

This Associate Director role supports the US Pipeline Oncology Director in leadi...

Location

United States , Philadelphia; Durham; Collegeville

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Master’s degree or PhD in health economics and outcomes research, epidemiology, public health, biostatistics, or a related discipline
At least 1-3 years of experience the pharmaceutical industry and/or managed care, hospital, academic, or healthcare consulting environment with exposure to HEOR/RWE strategy and application
Know-how regarding the US payer/reimbursement and access environment and familiarity with how payer evidence needs inform evidence planning and deliverables (e.g., value evidence strategy, AMCP-style dossier content, budget impact/cost-effectiveness, payer-focused materials), gained through academic, internship, or professional experience
Expertise in RWE and economic evaluation study designs/methods evidenced by publications and/or contributing to study concept sheets and protocols (including clear research questions, endpoints, data source selection, and bias/confounding mitigation), reviewing/authoring key sections of statistical analysis plans and study reports, and ensuring publication/disclosure readiness in accordance with internal SOPs and external requirements
Strong communication and presentation skills, demonstrated by developing and presenting clear, decision-oriented materials (e.g., evidence strategy slides, executive readouts) and summarizing outcomes/next steps for senior audiences
Proven ability to prioritize, pivot, and manage multiple projects simultaneously in a matrix environment

Job Responsibility

Evidence strategy and planning: Co-develop and maintain US RWE & HO plans for 1–2 priority pipeline assets/indications, aligned to US medical, payer, and access needs
translate strategy into actionable workplans, timelines, and resourcing proposals
Study leadership (RWE/HEOR): Own day-to-day leadership for assigned real-world evidence and health outcomes studies (e.g., real-world evidence studies, cost-effectiveness/budget impact analyses, burden of illness, treatment patterns, patient-focused outcomes) including design and execution in partnership with internal functions and external vendors
Cross-functional stakeholder management: Support the US Pipeline Oncology Director in running cross-functional evidence strategy forums and asset-specific meetings by developing agendas/materials, surfacing options, documenting decisions, and tracking actions to closure
Scientific communication and quality: Draft/review project specifications, protocols, statistical analysis plans, study reports, abstracts, posters, and manuscripts
ensure adherence to SOPs and high scientific/operational quality
Trial design input for US relevance: Provide feedback to Clinical Development and cross-functional teams on optimal trial design to ensure enrollment of US-relevant patient populations and collection of endpoints/outcomes that support US stakeholder needs (e.g., health-related quality of life, patient-reported outcomes, resource utilization, and other health outcomes measures)
Internal decision support: Provide RWE & HO input to internal decision-making during development and commercialization planning (e.g., trial design considerations, data gap assessments, value messages, evidence prioritization and sequencing)
Marketed product support : Contribute ~20% effort to US RWE & HO strategy and execution for a marketed product in endometrial and rectal cancer, including data generation planning, cross-functional alignment, and delivery of analyses/publications that support lifecycle evidence needs and value communication
External insight generation: Maintain strong alignment with Field Based Payer Medical Teams and other field stakeholders to obtain customer insights

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

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Statistics Director, Oncology

Job Description

Job Responsibility

Requirements

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