Biostatistician or Sr. Biostatistician

Location
Emeryville, CA, United States
Posted
Jul 18, 2021
Ref
1070
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY DESCRIPTION:

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts. This office is home to about half of our 300-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL).

We are in search of top talent to help us meet our important goals and large growth plans.

ABOUT THE POSITION:

The primary responsibility of this Biostatistician or Senior Biostatistician position is to provide statistical support to clinical projects across multiple disease areas at Santen Inc. Depending on interest the position may also contribute to data mining of clinical data, real world data, and digital data. Additional responsibilities include facilitating the execution and data analysis of clinical trials and data collection activities. This position collaborates with other statisticians in directing the programming and data management team during the collection, electronic storage, manipulation and execution of the analysis of all clinical data using clinical information systems.

This position can range from entry level to experienced professional, depending upon the candidate.

ESSENTIAL DUTIES AND KEY DELIVERABLES:
  • Provides statistical support to the planning, implementation, and maintenance of clinical data collection and analysis, statistical result reporting, and quality control for Santen clinical trials.
  • Performs exploratory statistical analysis to meet the needs for planning and clarifying purposes.
  • Works closely with SAS programmers and Study Statistician to create SDTM and ADaM specifications and datasets.
  • Works closely with clinicians and Study Statistician to write Statistical Analysis Plans (SAP).
  • Provide statistical supports for Global Medical Affairs group for publications and presentations.
  • Modeling and simulation to guide design and clinical development decisions and choices
  • Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program
  • Contribute to external statistical community through presentations, publications, and service in cross-industry initiatives
  • If applicable, contribute and lead data mining and data sciences activities, including incorporation of novel data types, to inform clinical trial design, reverse translation, and clinical development decision-making

QUALIFICATIONS:
  • MS degree with ~3+ years of experience, or Ph.D. with ~1-5+ years of experience.
  • Pharmaceutical or related industry experience with clinical trials.
  • Understanding of clinical trial data and extremely hands-on in analysis and reporting of clinical trial data.
  • Strong SAS and R programming skills.
  • Basic knowledge of Electronic Data Capture system and CDISC standards including SDTM and ADaM.
  • Excellent verbal, written and organizational skills.

LOCATION:

Emeryville, CA preferred