Biostatistician Jobs
Cincinnati, OH
Job Summary
Acts as the Principal statistician for Kendle projects with any complexity. Commonly performs the following activities: assists in marketing and bidding efforts, serves as department resource for any statistical questions, acts as the primary (back-up) contact with the sponsor for all biostatistics related activities, writes (or review) statistical analysis plans (SAPs), helps manage clinical trials efficiently by providing accurate and consistent information to both sponsors and Kendle business/functional units.
Core Responsibilities
Plan/implement biostatistical components of clinical trials, as required by the sponsor, including any or all of the following:
Assists in marketing efforts by presenting at sponsor meetings and preparing presentation material
Assists in bidding efforts by developing and reviewing bids
Maintains a good working knowledge of clinical drug development, ICH and other regulatory guidelines, and biostatistics in order to effectively serve as a statistical department resource, mentors biostatisticians on job skills and statistical programming, oversees or develops training plans or materials for Biostatistics associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel
Assists 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; sample size calculations may require some literature search to ensure that the study assumptions are correct
Participates in DSMB or DMC activities including writing guidelines and serving as an independent statistician
Reviews Case Report Forms (CRFs) and ensures their design meets the protocol criteria and captures all data required to support a high quality database and the planned analysis
Attends investigator meetings or sponsor meetings and presents statistical aspects of planned study, if required
Generates and reviews randomization schedule(s) to ensure that there are no errors present and sponsor and protocol requirements are met
Validates IVRS randomization implementation to ensure that there are no errors present and sponsor and protocol requirements are met
Writes and reviews SAPs based on the protocol and develops organized, well-presented mock-up displays for tables, listings, and figures adhering to the SAP in collaboration with sponsor, if required
Reviews and approves tables, figures, and listing specifications to ensure that there are no errors present and sponsor requirements are met, jointly with project team
Provides statistical programming support to statistical programming associates if necessary
Reviews SAS annotated CRFs, SAS database design, data validation plans to ensure that there are no errors present and sponsor and statistical requirements are met
Participates in project teams as Biostatistics representative or Biometrics team leader by leading the Kendle team for Clinical Data Management (CDM), Statistical Programming and Biostatistics
Conducts effective meetings appropriate in format, frequency and attendees, distributes relevant information in advance, ensures minutes are promptly and accurately distributed, follows action items through to completion, maintains order and focus of meeting and works towards consensus
Establishes and negotiates accurate timelines with internal and external team members and Biostatistics management for completion of study related biostatistical activities
Monitors progress on project activities against agreed upon goals and ensures the study timelines for project deliverables are met
Recognizes and communicates project issues needing to be brought to the attention of the sponsor or other Kendle functional units (i.e., Safety, CDM, Regulatory etc.)
As needed, directs the activities of other Biostatistics personnel on assigned projects to ensure timely completion of high quality work
Perform plausibility checks on data and take the appropriate action to provide ongoing feedback to data management or if appropriate to resolve inconsistencies and to handle implausible values during analysis
Collaborates with project team and sponsor statistician to develop patient exclusion rules for per-protocol analysis and identifies patients who violate the protocol, if required
In accordance with the protocol and relevant SOPs determine when the study can be unblinded (when relevant) jointly with project team and sponsor
Reviews, prepares, and approves tables, listings and figures (TLFs) in collaboration with statistical programmers
Conducts and participates in validation and quality control of project deliverables as necessary
Performs model adequacy diagnostic tests
Ensures proper study closeout by documenting and archiving study related materials
Participates in results review meetings, if required
Writes/reviews statistical report and clinical study report, if required
Maintains positive working relationship with internal customers and Sponsor by keeping them up-to-date about progress of projects, working with them to develop coordinated plans that meet the customer needs and seeking out existing knowledge prior to developing new methods
Maintains open communication with internal and external customers by contacting sponsor counterpart on agreed upon schedule, responding to correspondence promptly and within agreed upon timeframes and choosing method of communication based on urgency and type of information being communicated
Evaluates and manages project budget against project milestones according to Kendle guidelines to ensure profitability
Assesses scope of work against client contractual agreement and identifies, suggests, processes, and follows to resolution change of scope orders when appropriate
Provides timely and effective input to job performance reviews for other Kendle associates as requested
Provides input to SOP development and reviews when necessary
Displays willingness to work with others and assists with projects and business unit initiatives as necessary to meet the needs of the business
Skills & Attributes
Candidate/incumbent should have an MS or a Ph.D. in Biostatistics or related field. An MS Candidate/incumbent should have a minimum of 8 years of experience and Ph.D. candidate/incumbent should have a minimum of 5 years of experience in clinical trials. Must have excellent knowledge in statistical theory including experimental design, categorical data analysis, analysis of variance (covariance), survival analysis, non-parametric methods. Must possess the ability to apply knowledge of statistical design, analysis, and programming techniques utilized in clinical research and to effectively communicate statistical concepts. Experience in SAS programming is required. Extensive knowledge of the drug development process and FDA and ICH Guidelines is required. Experience with regulatory submissions is preferred. Candidate/incumbent should possess excellent written and verbal communication. Ability to read, write, speak, and understand English is required.
For more information please call 800-733-1572
