Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers.  We currently have a challenging contract opportunity for a Senior Analyst III for our client in Cambridge, MA.

 

The Senior Analyst II will work within the Statistical Submissions and requires a person who is able to coordinate, prepare, review and handle Biostatistics electronic submission ready components for complex regulatory submissions. This individual is required to use SAS programming software, intensively, to review SAS programs and prepare the submission components. This is an analytical role and not a programming or coding position.

 

This role requires submission support for complex ad hoc and response requests from regulatory agencies. This candidate is also responsible for monitoring and meeting assigned project milestones and requesting resources while providing adequate submission status tracking reports, as well as metrics reports, to communicate progress and trends of electronic submission activities (i.e. submissions plans). Candidates may also develop or implement standard electronic submission practices and standards, while ensuring that they are employed across studies and drug programs.

 

SKILLS
In order to be successful within this role, qualified candidates should have great general computer proficiency, including Microsoft Suite applications, Adobe Acrobat and electronic submission applications utilized for electronic submission purposes.  SAS experience with some demonstrated programming language experience (CDISC) and knowledge of data sets and statistical analysis is also required.

 

Candidates must have a demonstrated ability in supporting project teams and managements with extensive knowledge and application of applicable industry principles, concepts, techniques, and standards.  Candidates must have full knowledge of applicable regulations and industry practices along with the ability to utilize the knowledge in practice.

 

EDUCATION/EXPERIENCE
Qualified candidates will have a Bachelors degree or equivalent, preferably in a scientific discipline (i.e. Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.) with 3 to 7 years of experience in the pharmaceutical, biotechnology industry or CRO.  Must have experience with clinical trial data and software used for electronic submissions purposes.  Regulatory experience is helpful, but not required.

If you meet the qualifications and requirements for this position, please Apply Now. Qualified candidates will be contacted.

Kelly Scientific Resources has grown into a $270 million global business as the scientific business unit of Kelly Services. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities.  We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com.