Biostatistician

COME AND WORK FOR US!!!!!

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Headquartered in San Antonio, Texas, Summit Clinical Research is an Integrated Research Organization dedicated to Non-Alcoholic Steatohepatitis (NASH) clinical trials, that delivers a full spectrum of study enrollment and site enrichment services to sites and sponsors in our network. From our inception in 2018, Summit has increasingly built a leadership team of uniquely specialized physicians, and clinical operations team professionals that span the health care industry.

At Summit, we strive to be on the forefront of innovative research by continuing to educate and expand our knowledge in the ever-changing landscape of Liver Disease treatment. As a network, we build upon each other’s successes to empower and inspire one another to achieve greater heights. Summit Clinical Research is committed to company culture, employee retention, and superior therapeutic areas of focus.

Summit Clinical Research is a fun dynamic company seeking a full-time, enthusiastic, engaging Administrative Assistant.  The right candidate will perform clerical and administrative functions in order to drive company success in a fast-paced clinical research environment. A professional demeanor and warm personality are a requirement. You must be a hard worker, have a strong work ethic, and have the ability to multi-task. Must be reliable...

Overall responsibility

The Biostatistician will provide a wide range of advanced statistical and programming expertise, guidance and support to the medical science team. The individual will be responsible for overseeing all biostatistics activities for assigned projects within the medical science department.  

 Key tasks:

• Supports in designing and delivering of metrics/reports that analyze study data and study/sites performance.

·        Plans and documents data file structure and develops, programs, and maintains complex statistical databases

·        Assists in the preparation of clinical trial documents and reports, protocol, scientific abstracts, and peer-reviewed manuscripts

·        Programs data listings/tables and patients’ profile to support medical monitoring activities

·        Acts as Subject Matter Expert and develops / works on new initiatives

·        Manages biometry vendors/CRO for medical science activities

·        Contributes to the improvement and standardization of Biometry processes and procedures, including the development of Biostatistics Standard Operating Procedures and Work Instructions

·        Maintains knowledge of current and emerging trends in statistical analysis methodology

·        Presents and shares knowledge at quarterly medical science meetings

·        Other duties as assigned

 Requirements:

• PhD degree in Biostatistics, statistics, or related field
• 3-5 years or more of pharmaceutical /biotech experience is preferred
• Knowledge of SAS and/or R Programming. Stata Programming is a plus.
• CDISC experience is preferred
• Demonstrated experience in providing statistical input and direction into the design of clinical studies, data analytic approaches, interpretation of findings and crafting of key messages
• Project management skills and familiarity with GCP, ICH guidelines and FDA regulation
• Excellent written and verbal communication skills
• Demonstrate ability to write documentation and understand, interact, and communicate effectively with others

The requirements listed above are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Supervisory Responsibilities:

None

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time

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