Principal Biostatistician FSP - Clinical Development
Job Description
As Principal Biostatistician, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-III clinical studies, with a focus on Neurology therapeutic area. This position reports to the Director of Biostatistics in FSP Services business unit in Cytel.
Responsibilities
You will contribute by:
ā¢ providing statistical support to clinical studies, with a focus on Neurology;
ā¢ participating in the development of study protocols, including participation in study design discussions and sample size calculations;
ā¢ reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
ā¢ performing statistical analyses;
ā¢ interpreting statistical results;
ā¢ preparing clinical study reports, including integrated summaries for submissions;
ā¢ leading study activities when called upon;
ā¢ utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
ā¢ serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
ā¢ being adaptable and flexible when priorities change
Qualifications
What we're looking for:
ā¢ Master's degree in statistics or a related discipline. PhD strongly desired.
ā¢ 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
ā¢ Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
ā¢ Knowledge and implementation of advanced statistical methods.
ā¢ Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
ā¢ Strong knowledge of ICH guidelines.
ā¢ Solid understanding & implementation of CDISC requirement for regulatory submissions.
ā¢ Adept in ADaM specifications generation and QC of datasets.
ā¢ Submissions experience
ā¢ Experience working with cross-functional teams, a Study Management Team (SMT) or similar teams for different clients.
ā¢ Effective communicator: able to explain methodology and consequences of decisions in lay terms.
ā¢ Team player; willingness to go the extra distance to get results, meet deadlines, etc.
ā¢ Ability to be flexible when priorities change and deal with ambiguity
Apply tot his job
Apply To this Job
As Principal Biostatistician, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-III clinical studies, with a focus on Neurology therapeutic area. This position reports to the Director of Biostatistics in FSP Services business unit in Cytel.
Responsibilities
You will contribute by:
ā¢ providing statistical support to clinical studies, with a focus on Neurology;
ā¢ participating in the development of study protocols, including participation in study design discussions and sample size calculations;
ā¢ reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
ā¢ performing statistical analyses;
ā¢ interpreting statistical results;
ā¢ preparing clinical study reports, including integrated summaries for submissions;
ā¢ leading study activities when called upon;
ā¢ utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
ā¢ serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
ā¢ being adaptable and flexible when priorities change
Qualifications
What we're looking for:
ā¢ Master's degree in statistics or a related discipline. PhD strongly desired.
ā¢ 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
ā¢ Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
ā¢ Knowledge and implementation of advanced statistical methods.
ā¢ Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
ā¢ Strong knowledge of ICH guidelines.
ā¢ Solid understanding & implementation of CDISC requirement for regulatory submissions.
ā¢ Adept in ADaM specifications generation and QC of datasets.
ā¢ Submissions experience
ā¢ Experience working with cross-functional teams, a Study Management Team (SMT) or similar teams for different clients.
ā¢ Effective communicator: able to explain methodology and consequences of decisions in lay terms.
ā¢ Team player; willingness to go the extra distance to get results, meet deadlines, etc.
ā¢ Ability to be flexible when priorities change and deal with ambiguity
Apply tot his job
Apply To this Job