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
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