Biostatistician I/II/ Sr Biostats/Prin Biostats

Acts as lead biostatistician on projects of moderate to very large, complex studies. Provides

mentorship to associate level Statisticians and Programmers. Writes and provides Quality

Review support for statistical reporting. Develops protocols

Responsibilities:

• Becomes familiar with the activities outlined in the department's Working Practice Documents and

contributes changes as needed. Learns and follows departmental procedures for statistical analyses and

programming work.

• Serves as a lead statistician on moderate and large projects.

• Leads a project team. Conducts team meetings, maintains project timelines, assesses resources needed,

provides resources, and prepares the budget. Ensures that SOPs are being followed and that

appropriate project documentation is ongoing.

• Coordinates with programmers and data management personnel as to database maintenance, updating

and documentation. Provides guidance for database structures for analysis.

• Creates or provides specifications for analysis databases based on Data Management database.

• Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical

design, and sound statistical analysis.

• Provides randomization schemes and appropriate documentation.

• Develops statistical analysis plan, including table and listing specifications, and guide others on the

team in its implementation.

• Programs/validates statistical tables with an emphasis o n efficacy endpoints. Provides proper documentation and oversee the work of others who assist in

programming/validating.programming/validating.

• Prepares and reviews reports, including interim reports, final Integrated Clinical and Prepares and reviews reports, including interim reports, final Integrated Clinical and

• Statistical Reports, Integrated Summaries of Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of safety, Integrated Summaries of

• Efficacy, and other documents and manuscripts. Contributes to the statistical Efficacy, and other documents and manuscripts. Contributes to the statistical methods section and methods section and verify for completeness and consistency for report.verify for completeness and consistency for report.

• Interacts with the sponsor on all aspects of the project.Interacts with the sponsor on all aspects of the project.

• Understands project budget as it relates to project work scope and communicate project budget as it relates to project work scope and communicate proactively with proactively with management concerning potential changes in work scope.management concerning potential changes in work scope.

• Provides general infrastructure support to the Biostatistics Department. Examples Provides general infrastructure support to the Biostatistics Department. Examples could include could include presentation/ teaching/presentation/ teaching at the Bios Department meetings, contributing at the Bios Department meetings, contributing to other general department to other general department documents or policies, assisting with Bios newsletter,documents or policies, assisting with Bios newsletter, helping in Bios department libraries, or training of helping in Bios department libraries, or training of new hires. Provides input to the new hires. Provides input to the Director and Associate Directors as to Director and Associate Directors as to hiring recommendations, hiring recommendations, department policies,department policies, and resourcing requirements and resourcing requirementsActs as lead biostatistician on projects of moderate to very large, complex studies. Provides

mentorship to associate level Statisticians and Programmers. Writes and provides Quality

Review support for statistical reporting. Develops protocols

Responsibilities:

• Becomes familiar with the activities outlined in the department's Working Practice Documents and

contributes changes as needed. Learns and follows departmental procedures for statistical analyses and

programming work.

• Serves as a lead statistician on moderate and large projects.

• Leads a project team. Conducts team meetings, maintains project timelines, assesses resources needed,

provides resources, and prepares the budget. Ensures that SOPs are being followed and that

appropriate project documentation is ongoing.

• Coordinates with programmers and data management personnel as to database maintenance, updating

and documentation. Provides guidance for database structures for analysis.

• Creates or provides specifications for analysis databases based on Data Management database.

• Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical

design, and sound statistical analysis.

• Provides randomization schemes and appropriate documentation.

• Develops statistical analysis plan, including table and listing specifications, and guide others on the

team in its implementation.

• Programs/validates statistical tables with an emphasis o n efficacy endpoints. Provides proper documentation and oversee the work of others who assist in

programming/validating.programming/validating.

• Prepares and reviews reports, including interim reports, final Integrated Clinical and Prepares and reviews reports, including interim reports, final Integrated Clinical and

• Statistical Reports, Integrated Summaries of Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of safety, Integrated Summaries of

• Efficacy, and other documents and manuscripts. Contributes to the statistical Efficacy, and other documents and manuscripts. Contributes to the statistical methods section and methods section and verify for completeness and consistency for report.verify for completeness and consistency for report.

• Interacts with the sponsor on all aspects of the project.Interacts with the sponsor on all aspects of the project.

• Understands project budget as it relates to project work scope and communicate project budget as it relates to project work scope and communicate proactively with proactively with management concerning potential changes in work scope.management concerning potential changes in work scope.

• Provides general infrastructure support to the Biostatistics Department. Examples Provides general infrastructure support to the Biostatistics Department. Examples could include could include presentation/ teaching/presentation/ teaching at the Bios Department meetings, contributing at the Bios Department meetings, contributing to other general department to other general department documents or policies, assisting with Bios newsletter,documents or policies, assisting with Bios newsletter, helping in Bios department libraries, or training of helping in Bios department libraries, or training of new hires. Provides input to the new hires. Provides input to the Director and Associate Directors as to Director and Associate Directors as to hiring recommendations, hiring recommendations, department policies,department policies, and resourcing requirements and resourcing requirementsBachelor's degree or equivalent and relevant formal academic / vocational qualification

• MS/MA degree in statistics, biostatistics, mathematics or related field and 5 years’ experience preferred

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:

• Strong SAS® programming skills (Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures

• Ability to provide mentorship and promote teamwork in a multi-disciplinary team setting

• Strong knowledge of statistical principles and strong statistical skills

• Ability to create study specifications and provide support in the review of data management documentation

• Proven performance of required tasks, as evidenced in outstanding performance in current tasks and/or documented record of accomplishments

• Evidence of strong management skills, as shown through management of multiple projects and/or staff members

• Excellent written and verbal communications skills

• Good organizational skills with the ability to adapt and adjust to changing priorities

• Positive attitude and the ability to work well with othersBachelor's degree or equivalent and relevant formal academic / vocational qualification

• MS/MA degree in statistics, biostatistics, mathematics or related field and 5 years’ experience preferred

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:

• Strong SAS® programming skills (Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures

• Ability to provide mentorship and promote teamwork in a multi-disciplinary team setting

• Strong knowledge of statistical principles and strong statistical skills

• Ability to create study specifications and provide support in the review of data management documentation

• Proven performance of required tasks, as evidenced in outstanding performance in current tasks and/or documented record of accomplishments

• Evidence of strong management skills, as shown through management of multiple projects and/or staff members

• Excellent written and verbal communications skills

• Good organizational skills with the ability to adapt and adjust to changing priorities

• Positive attitude and the ability to work well with others