Director, Biostatistics (SAS) – NC Pharma - Homebased
Our client, a NC-based biopharmaceutical firm with multiple products in development, is actively recruiting for a highly skilled, knowledgeable and collaborative Director level Biostatistician to join its R&D team.
The client is open to both on-site and remote candidates. It is a priority role and Company will pay generously to attract and retain a star.
This company is developing multiple products to treat cancer and other serious illnesses. The focus of the role will be to provide expert biostatistics support to the clinical development and regulatory submissions teams.
This is a highly collaborative role. This Director will work with cross-functional teams including Clinical Operations, Data Management, Clinical Pharmacology, Pharmacokinetics, Bioanalytical, Regulatory Affairs, etc. and we seek a candidate whose superb analytical and technical skills are complemented by superb communication, collaboration and leadership skills.
Specific responsibilities will include:
- Provides statistical leadership into all aspects of clinical trials, from design through statistical analysis and reporting.
- Develop standards and conventions for statistics, data management, and statistical programming.
- Act as lead statistician for several clinical trials within a project or across multiple projects.
- Involved in protocol development. Provides critical input into trial design, endpoints, and planned statistical analyses. Performs sample size calculations.
- Responds to requests for randomization schedules and serves as randomization specialist when randomization schedules are generated internally. Interacts as appropriate with IVRS vendor.
- Reviews case report forms and other data management-related documents. Evaluates and oversees the quality of clinical databases.
- Contributes to and reviews abstracts, posters, manuscripts and other external publications.
The right candidate will offer an advanced degree in in Biostatistics and 10+ years of experience providing high level statistical expertise in a biotech/pharma setting for clinical trials phases I - IV. Strong preference for candidates who are coming from a pharma/sponsor company.
Other priorities include:
§ Demonstrated ability to drive the statistical elements of clinical research including strong knowledge of statistical methodology and data standards, experience writing statistical sections of protocols and/or statistical analysis plans and experience with sample size software
§ Ability to program in SAS and other software required to analyze clinical data
§ Sound knowledge of the International Conference on Harmonization (ICH) guidelines, an understanding of the regulatory requirements from EU and US health authorities and of the submission process
§ Bkgd partnering with clinical development teams and providing astute interpretation of statistical results
§ Experience overseeing 3rd party partners involved in the process
This is an exciting company at an exciting time. Please forward Word resume for prompt consideration.