KP Recruiting Group is a consulting firm that providesleadership and exceptional talent to some of the world’s leading companies.Headquartered in the Midwest, KP Recruiting Group has successfully completedcountless engagements in the United States, Europe and Latin America. Werepresent clients in all industries and all sizes. Our mission is to provideexceptional client and candidate experiences in order to get the best possibleresults. On behalf of our client, we are excited to present the following confidentialrole. We look forward to hearing from you and discussing the opportunity!

The Role:

The project Leader is responsible for all programming activities at the project/indication level. In addition, contribute to the therapeutic area and department initiatives and task forces for innovation and process improvements.

Major Responsibilities:

Provide leadership, guidance, and hands-on support to ensure high quality and timely statistical programming deliverables within a project, ensure technical validity, compliance to internal standards and SOPs, regulatory requirements

Plan and execute statistical programming project activities, timelines, and resource use in cross-site global setting; provide justification for planned resource needs, seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas, with minimal direction from group head.

Ensure standardization and consistency in specifications and programming deliverables across individual studies and for integrated analyses

Provide technical guidance and leadership to metadata specifications and project/study specific data requirements

Lead regulatory submission activities, including electronic submission packages

Supervise the quality controls (QC) methods and processes for programming deliverables in both study and submission level activities

Provide guidance and mentor junior staff on programming techniques, project management and implementation of standards

Collaborate effectively with project statistician and with other functions in the aligned project team; participate in clinical project meetings and provide inputs, whenever relevant

Lead oversight activities for outsourcing engagements; guide team members to effectively interact with external resources

Requirements

Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.

MS / BS with at least 5 / 7 years of programming experience preferably in processing clinical trial data in the pharmaceutical industry

Excellent technical skills in statistical programming, with advanced knowledge in SAS and other statistical computing software (R, R-Shiny)

Ability to perform, coordinate and oversee the preparation, execution, reporting and documentation of all programming deliverables of a project, with minimal supervision

Knowledge on regulatory requirement evolution (SDTM, SDRG, ADRG, ADAM, XML format, etc.); thorough understanding of pharmaceutical clinical development (i.e., statistical concepts, techniques, and clinical trial principles) and ability to lead regulatory submissions

Ability to collaborate with external partners (CROs, Partners, etc.) and manage outsourced activities

Excellent verbal and written communication skills in an English global environment; ability to have efficient exchanges with partners, service providers, and colleagues across geographical locations

Benefits

Ourclient offers a comprehensive benefits package including:

401kMatching

Family andIndividual Insurance Packages (Health, Life, Dental, and Vision)

Paid TimeOff & Paid Holidays

Long &Short-Term Disability

IdentityTheft Plans

Retirement& Pension Plans

EmployeeAssistance Program

EmployeeReferral Program

TuitionReimbursement Programs

Advancement& Professional Growth opportunities 

ParentalLeave

& More

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$81k-110k (estimate)

POST DATE

03/10/2024

EXPIRATION DATE

07/09/2024

Overview of KP Recruiting Group

WEBSITE

kprecruiting.com

HEADQUARTERS

Minneapolis, MN

SIZE

<25

INDUSTRY

Business Services

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