Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons – firstname.lastname@example.org
- Assist in strategic planning and develop optimal clinical development plans with cross-functional drug development teams.
- Oversee multiple studies for one compound to ensure the consistency of statistical work standards.
- Responsible for writing statistical methodology section of the protocol, including sample size calculation.
- Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS or ISE.
- Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities.
- Direct the activities of internal and external statistical programmers to ensure the intended analyses are performed, and analysis data sets and their specifications are in place following CDISC standards.
- Review and comment on eCRFs, annotated eCRFs, edit checks documents and other clinical data management related documents.
- Lead the cross functional team to develop IWRS and oversee system testing.
- Participate in operations meetings and address issues related to biostatistics.
- Support and participate in the preparation of study reports, regulatory submissions, and annual IND safety update reports.
- Perform ad hoc analyses and validation of analysis results.
- Write simulation code and simulation report in compliance with regulatory agency requirements for adaptive design trials.
- Ph.D. in statistics/biostatistics with minimum 8 years of biopharmaceutical statistics experience; Master’s degree in statistics or biostatistics with a minimum of 10 years of experience with specific experience in late-stage drug development, including phase IIb, phase III, and submissions in the pharmaceutical industry.
- Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
- Experience in Biostatistics, SAS programming, and clinical data management in a regulated clinical research environment.
- Knowledge of missing data handling, multiple comparisons, and simulation techniques.
- Experience in organizing regulatory submissions such as BLA, NDA, sNDA, and MAA submissions.
- Good working knowledge of ICH, FDA and GCP regulations and guidelines
- Teamwork spirit.
- Experience in the neurology/cardiovascular therapeutic areas desirable.
Pay rate: $95-115 hourly W2 OR $115-135 hourly on 1099