Director, Bio statistics & Medical Affairs - United States
The Director, Biostatistics will be responsible for the overall statistical design and execution of Medical Affairs led studies that may include late phase trials, observational research, claims and health outcomes research, meta-analyses. Also responsible for support of scientific publications and data mining activities.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
- Provide statistical input for design, sample size, and protocol development for Medical Affairs Phase 4 studies.
- Participate in Publication Planning Meetings as a Bio-statistics representative; contribute to publication planning including timelines, statistical and analytical requirements for publications, projects, and publications plans.
- Develop, design, and oversee or perform post-hoc analyses of existing databases and meta-analyses as needed and appropriate.
- Familiar with the CDISC standard.
- Vendor management of statistical and programming support for the Medical Affairs team.
- Work collaboratively with other members of the Medical Affairs team to develop and provide scientifically sound analyses that answer questions to support and enhance publications and knowledge of company products.
- Generate publications, presentations, and posters in collaboration with Medical Affairs teams.
- Develop and manage a cross-functional data general plan.
- Build up knowledge in scientific methods for observational studies and market access strategies.
- Cooperate with clinicians, the Medical Communications team, and outcomes research scientists, data managers, and statistical programmers in the planning, conduct, and analysis.
- Train Medical Affairs staff in general and indication-specific statistical concepts.
- PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with 9 years of relevant work experience OR a Master’s degree in Statistics or Biostatistics or a related health science field, and 11 years of biostatistical experience in the clinical trials, post-marketing or health research environment.
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
- Excellent communication and interpersonal skills to effectively interface with others.
REQUIRED KNOWLEDGE AND ABILITIES:
- Experience with time-to-event data
- Strong statistical background
- Desire and aptitude to improve departmental processes and efficiency
- Excellent SAS skills including report generation. Willingness to be hands-on when needed. Knowledge of MS Office products (Word, Excel, PowerPoint).
- Knowledge and curiosity of currently acceptable statistical methodologies.
- Ability to work in a fast-paced environment
- Excellent organization and multi-tasking skills
- Strong interpersonal skills and problem-solving capabilities, Demonstrated ability to work in a team environment with clinicians, clinical monitors, data managers, programmers and medical writers.