Team Leader Biostatistician

Manages a small team within the department who are responsible for the statistical aspects of clinical trials from design through analysis and reporting, including client or regulatory interactions. Acts as the lead statistician, project lead, or senior reviewer on multiple projects. Contributes to study proposals and bids, representing the department at bid defenses.

Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Promotes all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good scientific, ethical, and regulatory standards.• Acts as lead statistician, project lead, or senior statistical reviewer on multiple projcts, manages project team resources, budget, finance, timelines and ensures SOP compliance with appropriate documentation.• Serves as the randomization statistician on selected projects.• Produces sample size calculations. Provides input into study design and statistical considerations, during protocol development. Reviews protocols for completeness, appropriateness of clinical design and sound statistical analysis. Contributes to writing appropriate protocol sections.• Prepares and reviews statistical reports, clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required. Contributes statistical methods section for integrated clinical statistical reports. Reviews integrated clinical statistical reports.• Provides internal teams and management with timely, accurate status and resourcing reports.• Assists in the training and implementation of departmental procedures or new industry knowledge for the team.• Assists in bidding and business development activities, as required.• Contributes to general infrastructure support to the department.Manages a small team within the department who are responsible for the statistical aspects of clinical trials from design through analysis and reporting, including client or regulatory interactions. Acts as the lead statistician, project lead, or senior reviewer on multiple projects. Contributes to study proposals and bids, representing the department at bid defenses.

Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Promotes all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good scientific, ethical, and regulatory standards.• Acts as lead statistician, project lead, or senior statistical reviewer on multiple projcts, manages project team resources, budget, finance, timelines and ensures SOP compliance with appropriate documentation.• Serves as the randomization statistician on selected projects.• Produces sample size calculations. Provides input into study design and statistical considerations, during protocol development. Reviews protocols for completeness, appropriateness of clinical design and sound statistical analysis. Contributes to writing appropriate protocol sections.• Prepares and reviews statistical reports, clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required. Contributes statistical methods section for integrated clinical statistical reports. Reviews integrated clinical statistical reports.• Provides internal teams and management with timely, accurate status and resourcing reports.• Assists in the training and implementation of departmental procedures or new industry knowledge for the team.• Assists in bidding and business development activities, as required.• Contributes to general infrastructure support to the department.Masters degree in statistics, biostatistics, mathematics or related field with 3 years experience, preferring at least 6 years of clinical trial experience as a statisticianPrevious experience that provides the knowledge, skills, and abilities to perform the job1 year of leadership responsibilityIn some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills and Abilities:• Strong knowledge of statistical principles underlying clinical trials and strong statistical skills• SAS® programming skills and familiarity of other statistical packages (eg StatXact, Nquery) and understanding of database structures• Good organizational skills across individual projects, managing own and team work loads• Capable of adapting and adjusting to changing priorities• Strong written and verbal communication skills• , including proficiency in the English language• Capable of working in a multi-disciplinary team setting• Positive attitude and the ability to work well with others• Basic knowledge of statistical principles applied to the design and analysis of clinical trials• Capable of interpreting and contributing to company policies• Strong problem solving skills• Good leadership/mentoring skills as shown by leadership of projects and team membersMasters degree in statistics, biostatistics, mathematics or related field with 3 years experience, preferring at least 6 years of clinical trial experience as a statisticianPrevious experience that provides the knowledge, skills, and abilities to perform the job1 year of leadership responsibilityIn some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills and Abilities:• Strong knowledge of statistical principles underlying clinical trials and strong statistical skills• SAS® programming skills and familiarity of other statistical packages (eg StatXact, Nquery) and understanding of database structures• Good organizational skills across individual projects, managing own and team work loads• Capable of adapting and adjusting to changing priorities• Strong written and verbal communication skills• , including proficiency in the English language• Capable of working in a multi-disciplinary team setting• Positive attitude and the ability to work well with others• Basic knowledge of statistical principles applied to the design and analysis of clinical trials• Capable of interpreting and contributing to company policies• Strong problem solving skills• Good leadership/mentoring skills as shown by leadership of projects and team members