Manage a team of Biostatistics staff. Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work. Communicate on project progress, staffing, and resource allocation with the Director, Biostatistics, as needed. Perform expert reviews jointly with other Biostatistics management staff. Participate in client meetings. Coordinate the development of new SOPs and develop training modules jointly with other department managers. Participate as senior statistician on major projects, including developing/reviewing protocols, preparing analysis plans, overseeing the conduct of analyses, and preparing integrated clinical and statistical reports. Provide training, guidance and mentorship to lower level and new staff.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Technical responsibilities: i) Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company. ii) Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses. iii) Represent clients at meetings with regulatory agencies or other regulatory meetings; may participate as a member of a Data and Safety Monitoring Committee. iv) As approved, participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication. v) May participate as high level lead biostatistician on major project(s) including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, ISSs, ISEs and/or NDA sections, as required.
- Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
- Participate in project meetings; keep up-to-date on project issues; keep Director informed of project issues.
- Coordinate and participate in process improvements and interoffice/interdepartmental task forces; oversee collection and reporting of Biostatistics metrics, implementation of revised work practices, new guidelines, and new software tools as they become available.
- Make recommendations about resource allocation so as to achieve target utilization rates and project realization rates.
- Assist in the following: (i) sales meetings as required; (ii) overseeing proposal preparation; (iii) ensuring that all proposals bid by the department have an adequate budget, and sufficiently detailed set of budget assumptions.
- Provide training, guidance and mentorship to lower level and new staff.
- Working knowledge of relevant Data Standards (such as CDISC/ADaM).
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Familiarity with most complex statistical methods that apply to Phase I-IV clinical trials
- In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials
- Strong working knowledge of SAS
- Excellent written and oral communication skills with good interpersonal skills
- Very good problem solving skills
- Excellent presentation skills
- Sound judgment/decision making
- Ability to lead and motivate a team
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
PhD in biostatistics or related field and 3 years relevant experience including 1 year in a leadership capacity; Master's degree in biostatistics or related field and 5 years relevant experience including 1 year in a leadership capacity; Bachelor's degree in biostatistics or related field and 7years relevant experience including 1 year in a leadership capacity; or equivalent combination of education, training and experience
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- Occasional travel