Principal Biostatistician - Immunology, Late Phase

Cytel Inc Wasilla , AK 99623

Posted 2 months ago

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

Cytel's Flexible Solutions Program (FSP) offers statistical programmers, biostatisticians and clinical data specialists amazing opportunities to work on client projects supporting clinical trial design and analysis.

The Principal Biostatistician will provide statistical leadership and influence for client's other 3rd party CRO resources as well as statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors. Additionally, will have oversight of statistical analysis plans, statistical outputs, and other documentation.

As a seasoned Biostatistician, will work primarily on Immunology: GI and Dermatology trials with a focus on Late Phase studies. Some PK Analysis experience highly desired.

Your Impact

  • Provide statistical input into study protocols, Case Report Forms, and data management plans, DSMBs and write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.

  • eSUB/submission

  • PK analysis and clinical pharmacology

  • Longitudinal data/analysis

  • Provide statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.

  • Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.

  • When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.

  • Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.

  • Contribute to the development of sourcing strategy for projects.

  • Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

What You Offer

  • Master's degree in Statistics, Biostatistics or related discipline

  • 5+ experience in statistical or biostatistical analysis supporting clinical trial operations for the pharma/biotech industry

  • Experience in late-phase trials required

  • Experience in immunology: GI and Derm studies required

  • eSUB/submission required

  • Experience with longitudinal data/analysis is preferred

  • Demonstrated team leadership for direct reporting relationships and leadership influence over indirect reporting relationships

  • Working SAS & CDISC knowledge required

  • Knowledge of PK/PD desired

#LI-JH1

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel's human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Principal Consultant Clinical (HomeBased)

Parexel

Posted 1 week ago

VIEW JOBS 9/16/2021 12:00:00 AM 2021-12-15T00:00 Are you dedicated to Public Health? Committed to making a difference? But you feel like you've hit a ceiling professionally and you're unsure of the next step in your career… Well, Parexel Consulting is growing and we're seeking experienced Clinical professionals just like you who are passionate about drug development and who are looking for opportunities to stretch your thinking, advance professionally, and present/execute solutions for our clients. Now is the time to join this DYNAMIC Group within our Parexel Regulatory Services Team! As a Principal Consultant you will provide expertise, solutions, and strategy to various clients on exciting products in various stages of development. You will work alongside a distinguished team of Subject Matter Experts who have a wealth of Industry and FDA experience, along with a wide variety of Technical Expertise! A Principal Consultant within the Parexel Consulting Organization must be a nationally recognized professional in their field of expertise with well-developed and proven rainmaking skills. Must have a comprehensive understanding of the organization's consulting models and methodologies, as well as, an extensive knowledge of what services PC provides. Provides a full range of consulting services and works within their personal area of expertise. Provides mentoring and guidance to junior team members on technical and/or business issues and supports knowledge-centered activities within PC. Project Execution * Works within a team environment or individually based on the project needs. Works within broad project guidelines and facilitates issue and conflict resolutions. * Prioritizes own work load and may prioritize the work load of the project team in order to achieve the project scope and objectives * Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action * Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions * Produces quality work that meets the expectations of PC and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met. Manages project engagements (small or large) * Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support * Provides guidance to project team members and acts as a mentor to junior staff Thought Leadership * Delivers presentations at seminars and industry group meetings * Authors articles for publication in industry magazines, newsletters, book chapters and other forums * May serve as a member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more professional associations. Contributes expertise to professional societies, academic or other similar groups influential in his/ her area of expertise * Drives knowledge-centered activities within PC as well as contributes to Parexel business process improvements. May contribute to new service and consulting model development Qualifications Consulting Activities and Relationship Management and Business Development * Applies the appropriate organization's consulting models and methodologies and assists in the design/improvement the methodologies when needed * Provides a full range of technical and/or business consulting services within personal area of expertise including representing clients to regulatory agencies * Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction * May act as a trusted advisor to clients, often on issues that lack precedence or are not clearly defined. May act as a loaned executive for a client * Facilitates resolutions to possible problems or conflicts within the project team and/or the client. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities * Develops business solutions addressing specific client needs using expertise, best practices and knowledge of the client's business and key industry drivers * Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization * Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referrals * Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account management * Actively prospects and leverages new business opportunities with client and industry contacts in collaboration with Account Management. Presents information about PC service offerings reflecting the organization's capability to support client needs * Generates new or repeat business due to personal name recognition or history of client satisfaction and/or relationship * Leverages rainmaking skills resulting in new and repeat business for Parexel. Is responsible for constant monitoring of his/her "A" list, and is expected to have continued contact with both existing and future potential clients * Participates in project scoping calls and proposal preparation, delivers sales presentations and participates in bid defense meetings when needed. Actively participates in account planning for key clients Education - MD or PhD required Language Skills - At least fluent vocal and written English Minimum Work Experience - Numerous years' experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design and authoring clinical sections of regulatory applications. Previous experience with a regulatory agency (such as the FDA or MHRA) in a Medical or Clinical Pharmacology Review is strongly preferred; however, candidates with strong industry backgrounds will also be considered. Travel Requirements - 30% Domestic or International travel EEO Disclaimer PAREXEL is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel Wasilla AK

Principal Biostatistician - Immunology, Late Phase

Cytel Inc