Senior Manager of Statistical Programming

Location United States of America
Discipline: Biometrics
Job type: Permanent
Salary: £Salary Range - $160,000-180,000
Contact name: Dan Sidell

Contact email: dan.sidell@rbwconsulting.com
Contact phone: 6179821238
Published: 30 days ago
Expiry date: 22 October 2021

Senior Manager of Statistical Programming

Location: Fully Remote

Looking to advance your career? Senior Manager level roles within the Statistical Programming team at a top-5 global CRO!

We are searching for skilled leaders to lead one of three available groups in the statistical programming team. These roles will be 80-90% Line management and project management, with about 10-20% of hands-on technical work.

 

Duties may include:

  • Works closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate.

  • Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or global applications).

  • Manages project timelines and schedules of specific phases of projects and collaborates with internal personnel and outside customer representatives.

  • Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements.

Education, prior work experience, and specialized skills and knowledge:

  • Graduate degree in statistics, biostatistics, mathematics, computer science, biotechnology, or a related field with at least 5 years (or bachelor’s degree with at least 8 years) of SAS programming experience in Biotech, Pharma, Clinical Research Organizations (CRO), or other relevant organizations.

  • Experience in providing statistical programming support including developing programming specifications to early and late phase clinical trials and regulatory submissions (IND, NDA, MAA).

  • In-depth knowledge of CDISC standards for SDTM, ADaM and FDA electronic data submission requirements.

  • Excellent problem-solving skills.

  • Outstanding communication skills (verbal and written).

  • Ability to manage multiple projects in a fast-paced environment.