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