Be an early applicantLess than 25 applicants

Company

Original Job Post

Incyte · 4 days ago

Senior Principal Biostatistician

Wilmington, DE

Full-time

Onsite

Senior Level

5+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

BiotechnologyHealth Care

H1B Sponsorship

Comp. & Benefits

Insider Connection @Incyte

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Interact with members of the multidisciplinary project teams to establish project timelines.

Provide statistical input to study protocols.

Write statistical analysis plans.

Monitor internal and CRO project activities including timelines, deliverables and availability of resources.

Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures.

Interpret study results and provide review of statistical summary reports of study results for accuracy.

Assist in writing relevant sections of the clinical study report.

Participate and contribute to authoring of Clinical Development Plan.

Participate in pre-IND and NDA activities.

Participate in the development and enforcement of SOPs and guidelines.

Other responsibilities as required.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

BiostatisticsFDA/EMEA guidelinesDrug developmentSASEfficacy analysesData validationProject managementSAS programmingHealth authoritiesFiling strategiesIndependent workCommunicationMultivariate AnalysesBiomarker Analyses

Required

Ph.D. degree in statistics required.

5 to 8 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.

Demonstrate ability to work independently in project management and decision making.

Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.

Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.

Previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies are highly desirable.

Preferred

Knowledge of multivariate analyses and Biomarker analyses is a plus.

Company

Incyte

Glassdoor

3.6

Incyte is a drug discovery and development company which hopes to build a proprietary product pipeline of novel small molecule drugs.

Founded in 1991

Wilmington, Delaware, USA

1,001-5,000 employees

http://www.incyte.com

H1B Sponsorship

Incyte has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (22)

2022 (37)

2021 (34)

2020 (34)