Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com
The Biostatistician is responsible for providing statistical support and implementing statistical methodologies to ensure statistical components are accurately specified and conducted; and to ensure achievement of statistical deliverables with high efficiency and quality prepared on time for company projects.
Primary Responsibilities and Accountabilities:
- Perform all additional analysis requested for multiple clinical trials, observational studies by cross functional team.
- Good understanding of real world evidence data and able to engage and explain statistical issues and concepts.
- Identify any statistical bias in the interpretation of clinical data and identify techniques used to avoid any bias.
- Able to understand the customers need and able to translate customer’s business problems into analytical problems.
- Collaborate with statistical programmers and other functions to meet the deliverables.
- Participate and interact with clinical and cross-functional teams
- Generate randomization schedule or review randomization schedule
- Review data management-related documents including but not limited to CRFs, database structure and data specification, edit checks specifications, data transfer specifications, and data management plans.
- Prepare statistical analysis plan and create mock-up tables as per statistical analysis plan.
- Statistical programming to support statistical analyses and write and maintain SAS programs for statistical analyses.
- Participate in reviewing clinical study reports.
- Keep up-to-date with the latest statistical methods development related to clinical trials
- Perform other duties/tasks as required or assigned.
Qualifications:
- Master’s or PhD degree in Biostatistics or related field.
- Proficiency in statistical programming in SAS.
- Excellent verbal and written communication skills.
- Must be able to perform sample size calculation, write statistical analysis section for the protocol, SAP and carry out statistical programming for the analyses
- Must be able to work with minimum supervision.
- Work Experience:
- Minimum of 4-6 years of industry experience in leading statistical activities as a Biostatistician in supporting clinical trials.
- Minimum of 4 years of SAS programming experience and knowledge of CDISC requirements.
- Proven ability to manage multiple projects across therapeutic indications.