Biostatistician Jobs
Wilmington, NC
Job Summary
Act as the lead or back-up statistician for Kendle projects with low to moderate complexity. May act as the supportive statistician for Kendle projects with any complexity working under the supervision of senior biostatistics personnel. Commonly performs the following activities: act as the primary or back-up contact with the sponsor for all biostatistics related activities, program or verify statistical table, listings, figures, and analysis datasets, write (or review) statistical analysis plans (SAPs), monitor the progress of biostatistical clinical trial activities against milestones and ensure that study timelines for project deliverables are met.
Core Responsibilities
Plan/implement biostatistical components of clinical trials, as required by the Sponsor, including any or all of the following:
Collaborate on 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.
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.
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.
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.
Participate in project teams as Biostatistics representative, interfacing as necessary with Kendle Clinical, Safety, Statistical Programming, Clinical Data Management (CDM) or other Kendle personnel as necessary to discuss any project issues related to statistics.
Establish accurate time estimates for completion of study related biostatistical activities and communicate timelines to project manager, Biostatistics management and the project team.
Ensure the study timelines for project deliverables are met.
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
Collaborate with project team and sponsor statistician to develop patient exclusion rules for per-protocol analysis and identify 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.
Produce, verify, review, and approve tables, listings and figures (TLFs) in collaboration with statistical programmers and biostatisticians which comply with the requirements of the SAP and protocol and meet the quality standards of an independent reviewer and sponsor.
Conduct and participate in validation and quality control of project deliverables ensuring that output meets the expected results.
Perform statistical analysis and perform model adequacy diagnostic tests.
Ensure proper study closeout by documenting and archiving study related materials.
Participate in results review meetings, if required.
Write and review statistical reports and clinical study report, if required.
Provide timely and effective input to job performance reviews for other Kendle associates as requested. Perform budget reviews and maintenance.
Display willingness to work with others and assist with projects and business unit initiatives as necessary to meet the needs of the business.
DEVELOPMENTAL RESPONSIBILITIES
May assist in the training of other statisticians and statistical programmers by developing training courses, presenting training materials, mentoring new associates, reviewing work and providing feedback.
May assist in marketing efforts by presenting at sponsor meetings and preparing presentation material.
May assist in bidding efforts by developing and reviewing bids.
May support DSMB activities including writing guidelines and serving as an independent statistician.
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.
Provide input to SOP development and review when necessary.
May act as Biometrics team leader by leading the Kendle team for Clinical Data Management, Statistical Programming and Biostatistics.
Skills & Attributes
Candidate/incumbent should have an MS or a Ph.D. (or equivalent degrees) in Biostatistics or related field. An MS Candidate/incumbent should have a minimum of 2-3 years of experience and Ph.D. Candidate/incumbent should have some experience in clinical trials. An equivalent combination of education and experience may be accepted as a substitute for the specific education and experience requirements. Must have a good working knowledge of statistical theory including experimental design, categorical data analysis, analysis of variance (covariance), survival analysis, non-parametric methods. Must possess ability to apply knowledge of statistical design, analysis, and programming techniques utilized in clinical research and to effectively communicate statistical concepts. Experience with one or more statistical software packages (preferably SAS) is required. Must be familiar with the drug development process, ICH guidelines and other regulatory requirements related to biostatistical activities. Candidate/incumbent should possess effective written and verbal communication. Ability to read, write, speak, and understand English is required.
For more information please call 800-733-1572
