דרושים Senior Principal Biostatistician ב-Incyte ב-United States, Wilmington

Director, PMO (Project Management Office) Capacity Management Leadoperations, financial processes, and resource management concepts.This role will provide support and guidance to key R&D partners on capacity management systems, tools, data, and processes. You will lead the design, and support the development and delivery, of various activity-based models within our Planisware system.

Key Responsibilities

• Clinical Cost Modeling: Lead the creation of robust cost models for clinical trials, factoring in variables such as patient recruitment, site management, drug supply, and regulatory requirements. Refine cost models for clinical trials, incorporating financial assumptions and benchmarks.
• Activity-Based Forecasting: Oversee the development of forecasts for clinical trial activities, incorporating timelines, resource demands, and project milestones to guide R&D planning. Direct the calculation of estimate to complete (ETC) while leveraging remaining timeline assumptions to ensure accurate projections and forecasts.
• Planisware Algorithm Oversight: Manage and validate Planisware algorithm models for financial forecasting, ensuring transparency in inputs (e.g., cost drivers, trial milestones), calculations (e.g., cost allocation formulas), and assumptions. Maintain clear documentation and reporting of Planisware algorithm inputs, calculations, and assumptions to support auditability and stakeholder confidence.
• Strat Plan, Budget, and Forecasts: Support annual budgeting and forecasting processes with workforce related financial insights. Support the alignment of financial and resource data with project and study assumptions for the annual Strategic Planning and Budget Processes. Provide information necessary to support quarterly Forecast and Monthly Planning and Control Processes.
• Orphan Drug Credits: Oversee the tracking and optimization of tax credits and incentives for orphan drug development, maximizing financial benefits
• Business Analysis and Reporting: Prepare and deliver recurring and ad-hoc financial reports to finance leadership and business partners. Provide actionable financial insights through variance analysis, cost-benefit analysis, scenario planning, and other reporting solutions. Translate complex financial/resource management data into clear, actionable insights for both finance and non-finance audiences. Analyze headcount, labor cost, and utilization data to support resource planning
• Cross-Functional Collaboration: Partner with Finance (FPA), clinical operations, regulatory, and development project management teams to ensure forecasting aligns with trial milestones and operational needs. Collaborate with the Business Intelligence Resources within the PMO Team to deliver requirements and develop dashboards to manage resource spending and capacity planning.
• Process Improvement and Oversight: Oversee the design, implementation, and standardization of forecasting and budgeting processes, ensuring consistency, efficiency, and compliance with industry best practices. Lead initiatives to identify inefficiencies, streamline workflows, and implement process enhancements to improve forecasting accuracy and budgeting effectiveness.

Additional Responsibilities

• Advanced Analytics and Forecasting Innovation

Investigate alternative design approaches for forecasting and capacity management, ensuring scalability, flexibility, and alignment with organizational goals. Lead discussions on system transitions, model redesigns, and the incorporation of advanced analytics to support long-term strategic objectives.

Qualifications

Bachelor’s degree in Finance, Accounting, Business Administration, Life Sciences, or a related field (MBA, CPA, or advanced degree preferred)

10+ years of experience in financial planning, forecasting, or budgeting within pharmaceutical R&D or a related industry.

Proven expertise in clinical cost modeling, activity-based forecasting, portfolio management, and process improvement.

Experience with Planisware or similar systems for resource and financial management.

Skills and Competencies:

• Deep understanding of pharmaceutical R&D processes, including clinical trial phases and clinical trial budgeting models.
• Strong analytical and financial modeling skills, with proficiency in advanced analytics and forecasting algorithms.
• Experience working with AI-based models for forecasting, including knowledge of machine learning frameworks and data science principles.
• Ability to ensure transparency through documentation of forecasting models, including inputs, calculations, and assumptions.
• Ability to partner with technical and operational teams to drive financial insight while managing multiple priorities
• Strong business acumen with the ability to work independently and manage multiple priorities.
• Understanding of project-based accounting or resource planning principles.
• Excellent leadership, communication, and stakeholder management skills.

Technical Proficiencies:

• Advanced proficiency in Planisware, ERP systems, and financial reporting tools; Proficient in Excel and financial reporting tools; experience with SQL, Power BI, Tableau, or similar platforms preferred.
• Familiarity with financial systems (e.g., Oracle, SAP, Adaptive Insights, Hyperion) and project costing concepts.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

The Principal Biostatistician is responsible for providing statistical support for drug development programs in all phases of development.

Essential Functions of the Job (Key responsibilities)

• Participate in the development and enforcement of SOPs and guidelines.
• Participate in pre-IND and NDA activities.
• Participate and contribute to authoring of Clinical Development Plan.
• Assist in writing relevant sections of the clinical study report.
• Interpret study results and provide review of statistical summary reports of study results for accuracy.
• Provide guidance and support to team members in creating analysis dataset specifications and programming of tables, listings, and figures.
• Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
• Write statistical analysis plans.
• Interact with members of the multidisciplinary project teams to establish project timelines. Provide statistical input to study protocols.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Familiarity with multivariate analyses and biomarker analyses is beneficial.
• Experience in collaborating with health authorities, including discussions and negotiations in filing strategies, is highly desirable.
• Proficiency in using SAS to perform efficacy analyses and validate important data derivations when necessary.
• Able to effectively communicate their ideas and to manage team members in a constructive manner.
• Demonstrate ability to work independently and collaboratively in project management and decision making.
• Experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics is preferred, but not required. We welcome candidates with diverse backgrounds and experiences.
• Advanced degree in statistics or equivalent experience preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

The Biostatistical Programmer to Principal Biostatistical Programmer is responsible for processing clinical data required for statistical analysis of Phase I — III clinical trials and leading project teams.

Essential Functions of the Job (Key responsibilities)

• Conduct statistical programming work of clinical data using SAS Software.
• Ensure that all programs, outputs and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs.
• Generate analysis datasets according to CDISC standard and SAP.
• Implement analysis methods according to SAP, and produce summary tables, graphs and data listings using SAS; Conduct ad hoc analyses.
• Validate programs and associated results produced by other programming team members
• Participate in TLF shell preparation and review, and assist statistician for SAP preparation.
• Run CDISC validation programs e.g. OpenCDISC reports to ensure ADaM datasets are CDISC compliant.
• Develop standard SAS macros for efficient analyses of clinical data under the guidance of Programming management.
• Participate in the review of 'Statistical Analysis Plan' and other documents essential to the conduct of statistical programming work for clinical trials.
• Collaborate with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure quality, timelines, and deliverables are met. Work independently to program for individual studies with minimal supervision.
• Work independently to program for individual studies with minimum supervision.
• Function as a Lead programmer for a project or a group of studies performing the following functions:
  • Maintain the overall timeline for their studies.
  • Maintain the programming standards for their studies.
  • Review standard macros used.
  • Review standard datasets used.
  • Discuss the need for programming resources for the group of studies.
  • Guide and support team members on Incyte systems and standards as they work on studies within their area.
  • Assist less experienced programmers in new study set-up to help identify similar studies.
  • Review Production area after study programming is complete to make sure datasets, programs, and outputs are properly stored.
  • Check that the validation summary reports are clean of errors and warnings, and show proper documentation of SAS programs.
  • Review individual study CDISC validation output.
• Act as a Programming lead for a submission project under supervision of Programming management.
• Serve as a mentor to less experienced programmers and as an expert to provide recommendations and solutions to complex problems.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Discover – Develop – Deliver – Collaborate
• Strong organizational, time management, communication and project coordination and leadership skills.
• Demonstrate knowledge of regulatory guidelines, including electronic submission standards.
• Good SAS programming skills and attention to detail are essential.
• Experience with data management, including familiarity with CDISC standards, is highly desirable.
• Minimum of several years of programming experience using SAS/Base/Macro/GRAPH in the biopharmaceutical and/or CRO industries, or equivalent skills and knowledge.
• A degree in a relevant field such as statistics or computer sciences is preferred, but equivalent practical experience will also be considered.
• Demonstrate experience in mentoring team members and providing expert recommendations and solutions to complex problems.
• Must be able to manage multiple tasks while collaborating with team members effectively.
• Must be able to effectively manage workload and prioritize tasks in a dynamic environment.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

Essential Functions of the Job (Key responsibilities)

·Assists in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans, and other supporting documents.

·Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted). Update template for new risks and new amendments information.

·Participate in the feasibility and evaluation of investigative sites; working closing with the Clinical Trial Logistics group.

·Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization.

·Assist in the development and management of study timelines and priorities, including recruitment tools/strategy and patient retentions plan.

·Plan and organize meetings with team support (eg. investigator/coordinator meetings, DMC, SMC, safety call, etc.).

·Assist in the development of the IP and co-medication strategy (Quantities, labels, depots, tracking, etc.) working closely with other departments.

·Participate in data review and discrepancy resolution.

·Participate in coordinating efforts with internal Pharmacovigilance, and safety group.

·Monitor study-specific timelines and key deliverables; focus on management of all external vendors (e.g Monitoring, Sample management, IVRS, Laboratory, etc).

·Participate as a member of the multi-disciplinary trial(s) team.

·Develop relationships with investigational sites and institutions to enhance conduct of the trial.

·Acts as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway.

·Assume responsibility to participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department.

Qualifications (Minimal acceptable level of education, work experience, and competency)

·BS/BA degree or a relevant degree with strong emphasis on science.

·Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience.

·Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.

·Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.

·Prior experience in assisting the conduct and management of multinational clinical trials is preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Responsibilities:

• Serve as a DMPK project lead on discovery project teams. Initiate and engage in multifunctional collaborations to facilitate the advancement of drug candidates and build thorough knowledge of drug candidate properties.
• Responsible for the design and interpretation of preclinical DMPK studies necessary for the selection of clinical candidates.
• Ensure adequate characterization and liability assessment to support candidate nomination and clinical dose projections.
• Responsible for writing PK reports, and author DMPK sections for regulatory submissions and IB updates.
• Develop interdisciplinary collaborations and ensure that key DMPK data, information, and priorities are integrated into overall project team strategy.

Minimum Requirements

• PhD or equivalent with 5+ years of industry experience in PK.
• Strong working knowledge of ADME (in vitro, in vivo, in vitro-to-in vivo) and pharmacokinetics with hands-on experience using PK software tools (e.g., WinNonlin, Gastroplus) is required. Knowledge and expertise in modeling such as PBPK and PK/PD is preferred.
• Experience as a DMPK project lead in discovery programs is preferred.
• PK knowledge and experience with biologics and protein degraders is a desirable plus.
• Appropriate understanding of applicable FDA and European regulations with experience in IND filing and clinical protocols is a plus
• Excellent oral and written communication skills are essential along with strong organizational skills.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)
This position is responsible for working with the physicians within Clinical Development to co-lead and provide clinical research support for programs as assigned by phase or therapeutic area.

Essential Functions of the Job (Key responsibilities)

• Design and author protocols for clinical studies
• Responsible for providing clinical input into eCRF design, SAP, and TLFs.
• Collaborate with study team members to conduct timely and thorough review of study data using best practices and available tools to identify and evaluate data trends.
• Provide clinical updates on assigned compounds/programs to Sr. management, Project Teams, Joint Project Teams and/or Steering Committees (if appropriate), Clinical sub-teams, internal strategy and governance meetings, eDMC meetings, steering committees, advocacy groups, scientific advisory boards, and publications committees
• Lead or co-lead the ICF risk language across a compound to ensure a consistent approach
• Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans
• Maintain alignment with the asset Global Lead, Operational Asset Lead, and Global Product Strategy Lead
• Lead, co-lead, and contribute to the review of clinical sections of documents such as IND, IND amendments, Investigator Brochures, oncology unique CRFs, Annual Reports and other Health Authority submissions
• Manage relevant issue escalation to resolution, as items arise on Clinical Development Programs
• Coordinate, lead, and provide clinical input on internal and external slide presentations to ensure consistency of content
• Attend and present at various meetings with internal and external stakeholders (eg, investigator meetings, scientific advisory boards, etc)
• Develop relationships with appropriate consultants and External Experts and utilize these relationships to obtain feedback on protocol design and compound strategy
• Clinical lead for abstracts, posters, oral presentations, and manuscripts for assigned compounds
• Contribute or lead process improvement initiatives
• Provide mentoring, leadership, guidance, and clinical science expertise to Incyte personnel to enable proper decision-making
• Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest
• Liaise with cross functions on training of current studies, results, meeting with lead PIs/KOLs at conferences; present as needed
• Liaise with key translational medicine leadership on strengthening and implementing a biomarker plan from a clinical point in development studies for a consistent approach as applicable
• Consult when/if asked by Finances and Clinical Operations on the program budget and at times contribute as needed to the planning of trial/program budgets

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Degree in scientific/life-sciences field such as Master's, Pharm.D, or Ph.D/EdD degree preferred or equivalent experience
• Minimum of 10 years of experience in research with at least 6 years of drug development experience are required. Alternative drug development experience will be considered.
• Prior Oncology Drug Development experience required
• Global oncology trial experience and Health Authority experience are highly preferred
• Excellent written and verbal communication skills
• Strong analytical and strategic ability
• Ability to work independently and to multi-task large projects or compounds, ability to change pace and tasks as needed, and to work in a dynamic environment
• Knowledge of good clinical practice, FDA and EMEA/CHMP regulations, and guidelines
• Experience in managing team members is a plus.
• Ability to lead and/or be a proven leader in a line function responsibility, as well as having an ability to influence in a matrix global environment
• Have proven ability to drive decisions and manage in challenging business situations
• Ability to accommodate up to 20% travel or as business dictates

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary Function)

We welcome applicants from diverse clinical and scientific backgrounds including M.D., Pharm.D., Ph.D., Nurse Practitioner (NP), and Physician Assistant (PA) professionals who bring deep dermatology expertise and industry-relevant Medical Affairs experience.

Strategic & Scientific Leadership

• Serve as a Medical Affairs lead and subject matter expert in dermatology.
• Develop, track, and report on goals, objectives, and outcomes aligned with organizational strategy.
• Deliver clear and balanced scientific interpretation of clinical and real-world data to both internal and external audiences.

Stakeholder Engagement & External Collaboration

• Build and maintain trust-based relationships with external experts, healthcare professionals, and advocacy groups.
• Represent Medical Affairs at scientific congresses, advisory boards, and investigator meetings, promoting diversity and inclusion in engagement.

Cross-Functional Collaboration

• Partner with Commercial, Clinical Development, Safety, Regulatory, MSLs, and Training to align scientific and strategic initiatives.
• Provide scientific guidance for promotional material review via the Medical-Legal-Regulatory (MLR) Committee.
• Contribute to sales training, speaker development, and field team enablement.

Medical Evidence Generation

• Provide scientific oversight and serve as a medical reviewer or monitor for Investigator-Initiated Research (IIR) and Medical Affairs-led clinical trials or observational studies.
• Collaborate on study design, analysis, and publication strategy for evidence generation initiatives.

Required Education & Credentials (One of the following):

• M.D. or international equivalent
• Pharm.D., Ph.D. in life sciences or related discipline
• Nurse Practitioner (NP) or Physician Assistant (PA) with advanced clinical training and experience in dermatology

Professional Experience

• Minimum 2 years of direct Medical Affairs experience in the pharmaceutical or biotechnology industry, or equivalent in academia/clinical practice with industry-relevant roles
• Clinical or scientific expertise in dermatologic conditions such as atopic dermatitis, hidradenitis suppurativa, vitiligo, or other inflammatory skin diseases. Clinical practice experience in dermatology preferred
• Experience in Medical Affairs strategy, product launch, and evidence generation highly valued
• Experience with clinical trials, IIRs, and medical monitoring is preferred

Skills & Core Competencies

• Ability to communicate complex medical/scientific concepts effectively across audiences
• Strong understanding of clinical data analysis, translational medicine, and real-world evidence
• Demonstrated commitment to collaboration, diversity, inclusion, and teamwork
• Ability to educate, coach, and mentor internal teams and engage meaningfully with external stakeholders

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .