Current Openings

The AD/Director of Clinical Programming will lead technical efforts and provide needed programming support for assigned projects. 

Qualifications and Experience: 

· Bachelor’s degree in statistics, biostatistics or equivalent required. 

· Strong clinical/statistical programming experience with extensive knowledge of SAS.

· In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases.

· Must be able to work in a remote environment.

Conduct and report onsite monitoring visits. Responsible for site communication and site management.  Manage study activities, timelines, and schedules.

Qualifications:

·  Degree in Life Sciences or equivalent experience.

·  Strong independent on-site monitoring experience Phase I - IV.

·  Experience in multiple therapeutic areas. (Vaccine experience a plus)

·  Proficiency in MS Office applications.

·  Ability to plan, multitask and work in a dynamic team environment.

Provide clinical leadership to project teams and manage the day-to-day clinical operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations. You will work proactively to mitigate risk and solve potential challenges.

Qualifications:

• Minimum of 3 years experience as a CTM.
• Prior experience as a CRA.
• Experience in multiple therapeutic areas. 
• Global experience a plus.

Lead clinical trials from start up to close out.  Oversee and manage projects to ensure clinical trials are completed in a timely manner and within budget.

Qualifications:

·  Bachelor’s Degree or higher.

• Minimum 2 years of Project Management experience.
• Previous experience with a CRO preferred.
• Experience with Phases I-IV from start-up to close-out preferred.
• Knowledge of SOPs, ICH / GCP and local regulations.
• Strong communication, organizational, management and analytical skills.

Collaborate with clinical operations, statistics, data science staff, and external partners to ensure accurate, documented, and regulatory-compliant data.

Qualifications:

• Bachelor's Degree or higher.
• 3+ years of clinical data management experience in a life sciences organization.
• Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.
• Experience  with CDISC standards including SDTM and EDC software.
• Strong organization skills and attention to detail.

The Director of Biostatistics leads all statistical work for a product line during development and oversee the design, analysis, and reporting of clinical trials.

Qualifications: 

• A Ph.D in Statistics or Biostatistics - 10+ years of pharma experience.
• Solid  knowledge of complex statistical methods in clinical research.
• Experience with NDAs and  MAAs strongly preferred.
• A  proven history of helping prepare submission files (IND, CTD).