Senior Biostatistician

Essential Functions: 

• Participates in and contributes to the training and development of more junior biostatisticians

• Independently reads and comprehends study design and statistical sections of a protocol and appropriately adapts protocol language to a statistical analysis plan.

• Able to work with clients to procure operational design information for sample size calculations.

• Independently able to perform and QC sample size calculations.

• Able to independently review data management documents to assess quality of the documents to support statistical analyses.

• Independently develop Randomization specifications and programs based on study requirements.

• Prepares draft statistical analysis plans and shells.

• Able to perform review of draft SAP and shells produced by more junior biostatisticians.

• Reviews PD file for exclusion from analysis sets and implements into specifications and/or programs.

• Participates in unblinding activities and incorporates unblinded treatment codes into algorithms/programming

• Able to read and understand most SDTM & ADaM domains and mapping algorithms.   Able to review common domains independently. Understands the role that SDTM & ADaM plays in the standardization of clinical trials data/CDISC.

• Able to prepare specifications for moderately complex analysis data sets (CDISC and CDISC-like) independently or highly complex data sets with senior oversight.

• Able to develop programs to produce and perform statistical review of datasets, listings, tables and graphs as outlined by a statistical analysis plan.

• Able to effectively QC TLFs, SDTM and analysis data sets (ADaM/non-ADaM) independently.

• Able to effectively review the statistical section of CSR for statistical accuracy with minimal input from senior oversight.

• Able to maintain biostatistical section of TMF independently

• Able to attend project team meetings and contribute to project team discussion of project related issues

• Able to effectively interact with both internal and external clients on project issues.

• Respects and maintain the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with

• Able to keep detailed records of time spent on each project to allow accurate billing and maintains awareness of overall biostatistics budget and time spent on projects that they are assigned to lead.

• Develops and maintains overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.

• Deepens their knowledge of clinical research including awareness and understanding of how biostatistics interacts with other team members on a project.

• Perform other work-related duties as assigned

Necessary Skills and Abilities: 

• In-depth knowledge of statistical methodologies and how to apply them in a clinical research setting.

• Demonstrated working knowledge of advanced clinical trial design and analysis principles.

• Competent knowledge of CDISC standards and application of these standards to projects.

• Strong computer skills, with evidence of advanced programming skills (SAS or R) especially statistical inferential procedures

• Excellent English Communication skills (verbal, written & interpersonal).

• Detail oriented, well organized.

• Ability to multitask and work effectively in a fast-paced environment with changing priorities.

• Ability to be productive and handle multiple tasks to meet deadlines in a dynamic environment.   

• Excellent Communication and interpersonal skills, with the ability to work collaboratively in cross functional teams and with external partners.

• Excellent team player, collaborative and able to work as part of an effective team. Maintains a positive, results orientated work environment

Educational Requirements: 

• Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field. Equivalent combination of education, training and experience will be considered.

Experience Requirements: 

• 5 to 8 years' experience in clinical trials design and analysis  

• Outsourcing industry experience required. 

• Experience in clinical trial design, sample size calculations, and statistical analysis.  

• Experience with CDISC data structures, such as SDTM and ADaM.