Job Description
SENIOR BIOSTATISTICIAN
Join a top global CRO and act as the lead statistician for Kendle projects! Relocation assistance is available for qualified candidates. Senior Biostatisticians at Kendle are the primary contact with the sponsor for all biostatistics related activities!
CORE RESPONSIBILITIES: Plan & implement biostatistical components of clinical trials, as required by the sponsor, including any or all of the following:
Involved in the process of protocol development by choosing an appropriate study design including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, writing the statistical section of the protocol.
Review case report forms (CRFs) and ensure their design meets the protocol criteria and captures all data required to support a high quality database and the planned analysis.
Attend investigator meetings or sponsor meetings and present statistical aspects of planned study, if required.
Generate and review randomization schedule(s) to ensure that there are no errors present and sponsor and protocol requirements are met.
Validate IVRS randomization implementation to ensure that there are no errors present and sponsor and protocol requirements are met.
Write and review SAPs based on the protocol and develop organized, well-presented mock-up displays for tables, listings, and figures adhering to the SAP in collaboration with sponsor, if required.
Review and approve listing table specifications to ensure that there are no errors present and sponsor requirements are met, jointly with project team.
Provide statistical programming support to scientific programming associates if necessary.
Review SAS annotated CRFs, SAS database design, data validation plan to ensure that there are no errors present and sponsor and statistical requirements are met.
Establish and negotiate accurate timelines with internal and external team members and Biostatistics management for completion of study related biostatistical activities.
Monitor progress on project activities against agreed upon goals and ensure the study timelines for project deliverables are met.
Evaluate and manage project budget against project milestones according to Kendle guidelines to ensure profitability.
Assess scope of work against client contractual agreement and identify, suggest, process, and follow to resolution change of scope orders when appropriate.
As needed, direct the activities of other Biostatistics personnel on assigned projects to ensure timely completion of high quality work.
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REQUIREMENTS:
A Ph.D. in Biostatistics or related field with a minimum of 4 years experience in clinical trials is required. Must have excellent knowledge in statistical theory including experimental design, categorical data analysis, analysis of variance (covariance), survival analysis, non-parametric methods. Experience in SAS programming is required. Must be familiar with ICH guidelines and other regulatory requirements related to biostatistical activities. Candidate should possess excellent written and verbal communication.
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Kendle International Inc. is a premier provider of quality clinical development services for the pharmaceutical and biotechnology industry, with offices strategically located throughout North America, Latin America, Europe, Africa, and Asia/Pacific. One of the top 10 full service contract research organizations in the world, Kendle now operates 31 offices in 21 countries across 6 continents to better serve our growing base of global biopharmaceutical customers.
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