דרושים Biostatistical Programmer Principal ב-Incyte ב-United States, Wilmington

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.

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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 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 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)

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 .

Job Summary (Primary function)

The Sr. Principal PK/PD SAS Programmer processes PK/PD data required for Phase I — III clinical trials, develops SAS macros to facilitate data management and analyses, and performs exposure-Qtc analysis and exploratory statistical analyses on PK/PD relationship.

Essential Functions of the Job (Key responsibilities)

·Work independently to ensure the accuracy and quality of delivered results to satisfy the requirement of healthy authorities.

·Develop standard SAS macros for efficient analyses of clinical data which will be validated and can be production use.

·Interact with members of the multidisciplinary team to establish project timelines; computerized data validation checks and ad hoc requests.

·Design and implement statistical algorithms and code in conformance with defined programming processes and standard operating procedures.

·Ensure that all programs, outputs and documentation are consistent with relevance.

·Generate PK/PD analysis data sets and provide summary tables, graphs and data listings using SAS to support NCA or pop PK/PD analysis.

·Write statistical analysis plan and perform exposure-analysis on Qtc as requested.

·Work with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure timelines and deliverables are met.

·Assess data accuracy and consistency.

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

·BA/BS degree.

·Minimum 10 years of programming experience using SAS/Base/Macro/GRAPH in the biopharmaceutical and/or CRO industries.

·Data Management experience is highly desirable.

·SAS programming skills and attention to detail are essential.

·Demonstrated knowledge of regulatory biostatistics, SOPs, and guidelines.

·Highly motivated and able to work well independently

·May lead other jr. programmers

·Strong organizational, time management and project coordination 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)
Principal/Sr. Principal Investigator, AI driven Early Discovery Chemistry designs and synthesizes novel compounds that meet nomination criteria.

Essential Functions of the Job (Key responsibilities)

• Designs novel core structures/key structural elements for a new project based on HTS leads or published literature compounds.
• Coordinates efforts with CROs for the acquisition and/or synthesis of compounds to advance early discovery programs.
• Drives research projects, demonstrates the ability to formulate hypothesis based on experimental SAR data, proposes strategies and designs novel molecular targets to solve key medicinal chemistry issues related to potency, selectivity and ADME properties.
• Analyze FTO search report and provide suitable data for patent applications (including a well-documented laboratory notebook).
• Meets inventorship criteria as co-inventor on multiple patent applications.
• Present research results clearly to the department, other disciplines and at outside scientific conference.
• Design/conduct organic chemistry experiments to develop and optimize the synthesis of novel compounds.

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

• Ph.D. in Organic Chemistry or equivalent experience.
• 3 years of related medicinal chemistry experience.
• Understands basic patent law.
• Successful track record of significant contributions to the understanding of the structure activity relationships and ADME data for multiple discovery programs that lead to the identification of clinical candidate(s).
• Life-long learner: leverage extensive use of the literature to increase knowledge base in all aspects of medicinal and organic chemistry.
• Follow the safety rules and maintains a safe working environment.
• Team player: able to work with others in their group, department and company towards the common goal of inventing novel medicines and positively influences the culture of the group.

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 .