Groweing Sponsor client near Princeton, NJ is looking for a Manager of Biostatistics . Ideally this person can come onsite 1x per week, but client can consider remote on East Coast with ability for occasional travel.
- Manages or leads biostatistics assignments on multiple projects.
- Remains informed of new developments in biostatistics and programming that are relevant to the industry.
- Establishes and implements biostatistics and programming standards and complies with regulatory requirements among project team members and across studies.
- Programming in SAS and/or R for data analysis and reporting.
- Assists with statistical quality assurance review.
- Reviews deliverables before transfer to either internal or external clients.
- Performs statistical services to achieve timely, quality, and cost-effective deliverables including SAP, TLF shells and dataset spec development.
- Participates in the development of and ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines related to statistics and programming.
- Hands-on programming for TLF deliverables required statistical inference.
- MS degree in statistics or equivalent training required, PhD preferred
- A minimum of 6years of industry or CRO experience required
- Experience leading statistical projects in the pharmaceutical industry, demonstrated by the ability to independently function as the point of contact for statistics over all phases of clinical trials
- Proficient in industry standards, medical terminology, and clinical trial methodologies
- Possesses project management skills within the biostatistics function
- Regulatory (FDA and EMA) submission experience is not required but is considered valuable for an optimal candidate