Director / Associate Director, Biostatistics - San Diego, CA | Biospace
Get Our FREE Industry eNewsletter

Director / Associate Director, Biostatistics

Fate Therapeutics, Inc.

Location:
San Diego, CA
Posted Date:
5/18/2017
Position Type:
Full time
Job Code:
162JK
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Biostatistics, Oncology,

Job Description

Fate’s Biometrics team is currently seeking a skilled and motivated biostatistician to contribute to and manage the design and analysis of data for the Company’s clinical trials.  This is a full-time position reporting to the Vice President, Biometrics and is located at our corporate headquarters in San Diego, CA.

Responsibilities:
•   Advise and lead the strategy for statistical analysis for multiple clinical development programs
•   Primary statistical representation in regulatory interactions
•   Independent programming for complex statistical analyses and visualization
•   Scientifically sound and appropriately justified sample size calculations and randomization schemes for clinical trials
•   Cross-functional input into optimal database design
•   Statistical advice on the resolution of issues with clinical data
•   Input into Clinical Study Reports and related documents
•   Innovative and robust methods for ongoing pharmacovigilance monitoring
•   Input, authorship, review and approval of Statistical Analysis Plans and Table, Listing, and Figure specifications/shells and Standard Operating Procedures
•   Significant contributions to presentations at scientific meetings and publication in peer-reviewed journals as the primary statistical author
•   Management and mentorship of junior members of staff
•   Contributions to other tasks as required

Requirements

•   Masters or Doctorate degree in Biostatistics or closely-related field
•   10+ years of direct experience in drug/device development, or equivalent experience
•   Track record of professional development with increasing levels of responsibility in the design and analysis of clinical trial data
•   Strong knowledge of GCP, ICH, CDISC and other pertinent regulatory guidance
•   Willingness to develop/learn innovative statistical methodology
•   Experience in managing junior members of staff
•   Strong SAS programming experience
•   Experience in authoring and contributing to technical documents such as Statistical Analysis Plans, Clinical Study Reports, manuscripts and abstracts
•   Excellent communication skills
•   Strong team player
•   Ability to manage multiple competing priorities
•   Oncology clinical trial experience strongly preferred

Working Conditions and Physical Requirements
•   100% on-site work at corporate headquarters in San Diego, CA
•   Occasional evening and weekend work will be required
•   Ability to travel domestically and internationally up to 20% of the time


The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.

For consideration send cover letter and resume to:  careers@fatetherapeutics.com and reference job code 162JK.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders. The Company's hematopoietic cell therapy pipeline is comprised of NK- and T-cell immuno-oncology programs, including off-the-shelf product candidates derived from engineered induced pluripotent cell lines, and immuno-regulatory programs, including product candidates to prevent life-threatening complications in patients undergoing hematopoietic cell transplantation and to promote immune tolerance in patients with autoimmune disease. Its adoptive cell therapy programs are based on the Company's novel ex vivo cell programming approach, which it applies to modulate the therapeutic function and direct the fate of immune cells. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.