Sr. Biostatistician - Clinical Trials / Submissions / CDISC / FSP (Home-Based, USA)HireFlyer.com, Inc - Morrisville, NC
Location: Morrisville, NC
Employment Style: Any
Years of Experience: 3-5
Education Level: Master's Degree
Cytel’s FSP group is growing and hiring home-based Sr. Biostatisticians, to be a part of a highly hands-on team providing statistical support for Phase I-IV clinical trials, across a variety of therapeutic areas.
You will participate in the development of study protocols including participation in study design discussions and sample size calculations, and review CRFs and data review guidelines.
Additionally, you will:
•develop statistical analysis plans (SAPs) including analysis dataset and TLG specifications
•perform statistical analyses
•interpret statistical results
•help prepare clinical study reports including integrated summaries for submissions
This is a home-based position with the option to work at our King of Prussia, PA or Waltham, MA office locations.
What we need from you:
•MS or PhD in a science or industry-related discipline with five or more (5 ) years working on clinical trials.
•Experience in sample size calculation , protocol concept development , protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
•Good SAS programming skills for QCing critical outputs , Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
•Strong understanding & implementation of CDISC requirement for regulatory submissions.
•Adept in ADaM specifications, generation and QC of datasets
•Submissions experience strongly desired.
•Experience working with cross functional teams, a Study Management Team (SMT) or similar teams for different clients.
•Effective communicator : able to explain methodology and consequences of decisions in lay terms
•Team player ; willingness to go the extra distance to get results, meet deadlines, etc.
•Ability to be flexible when priorities change and deal with ambiguity
•Simulation and protocol design experience strongly desired.
•Experience in PK, PD, safety outputs and review a plus.
•Experience in any of the therapeutic areas highly desirable: Multiple Sclerosis, Immunology, CNS and Oncology.
Cytel offers a competitive salary, with an annual bonus incentive, excellent benefit’s package and the opportunity to GROW with us!
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
At Cytel we believe the clinical development of safe and effective medicines is crucial for human welfare. Our mission is to improve success rates in this endeavor via the optimal design, effective implementation and accurate data management of clinical trials. We believe that if you don’t get the trial design right, nothing else matters; and that every sponsor should evaluate the option of an adaptive approach. While Cytel may be best known for our pioneering work in adaptive approaches, our growing clinical research customers rely on Cytel strategic consulting, statistical programming and end-to-end data management expertise. As the world's largest biometrics CRO, all the major pharmaceutical, biotech and medical device companies are our customers along with scores of specialty and emerging sponsor companies. We also count among our customers and research partners the leaders in academia, at medical institutions and international regulatory agencies. www.cytel.com
13 days 3 hours ago
applySr. Biostatistician - Clinical Trials / Submissions / CDISC / FSP (Home-Based, USA) HireFlyer.com, Inc - Morrisville, NC, United States
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