Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Sr. Statistician is responsible for providing statistical support for clinical projects. May serve as the lead study statistician and contributes to the design, conduct, and reporting of clinical trials, with the support of a senior statistical reviewer. Works collaboratively with clinical development functions such as clinical research, data management, statistical programming, and clinical operations to ensure that overall project objectives and timelines are met.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Serves as study statistician under the supervision of a senior statistician, contributes to study design and protocol development (including sample size calculations), authors Statistical Analysis Plan including mock tables, listings, and figures (TLFs).
- Supports the data management team in reviewing the study database design and other aspects of data collection and review.
- Participates in clinical study team meetings, provides support as needed data review and cleaning, study monitoring committee meetings, and database lock.
- Reviews the final data results (TLFs), contributes to the statistical and results sections of clinical study reports.
- Carries out statistical analysis and prepares reports of data from clinical and pre-clinical studies as needed.
- Collaborates with other Clinical Development staff on posters and manuscripts for associated clinical study work.
- Provides statistical consultation and analyses as required to departments outside Clinical Development.
- Contributes to the development and maintenance of reporting standards, tools, and any other statistical applications as appropriate.
- Supports the development of biostatistics SOPs and standard processes.
- Updates skills continually with respect to evolving industry standards, statistical concepts, regulatory expertise and biological/therapeutic area knowledge.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Advanced degree (Master or PhD) in biostatistics, statistics, mathematics, or equivalent quantitative field.
- For Master level, at least 4 years of relevant experience as biostatistician in a pharmaceutical, biotech, CRO or other clinical research setting.
- Knowledge of statistical computing software including SAS or R. Experience with other software such as JMP, and nQuery a plus.
- Solid knowledge in statistical methodology and applications including linear and logistic regressions, survival analysis, and clinical trial designs.
- Experience with early phase clinical trials, vaccine and/or biologics development is a plus
- Working knowledge of GCP, ICH, FDA and HIPAA regulations and guidelines.
- Hands-on experience and basic knowledge in CDISC standards, including SDTM and ADaM, controlled terminologies, aCRF, cSDRG, ADRG, and define.
- Experience with writing statistical analysis plans, mock tables and specifications to meet regulatory and company standards.
- Good organizational, analytical and problem-solving skills
- Good written, verbal, and interpersonal communication skills.
- Ability to work as part of a team.
- Increased responsibility matrix management, and mentorship will be added as expertise and ability are demonstrated.
- Moderate independence on study design and conduct, with oversight, for basic biostatistical tasks is expected.