- Cambridge, MA
- Department: Research & Development
- Region: US
The Principal Biostatistician is responsible for providing the statistical expertise for company products within one or more therapeutic areas, He/She participates in protocol development, analysis plans and file/report specifications, and reviews study setup activities including but not limited to randomization, CRFs and data edits and serves as lead biostatistician assigned project(s). This person performs statistical analyses, interprets statistical results, and prepares clinical study reports including integrated summaries for submissions as appropriate. He/she also assists in preparation of responses to statistical issues arising in regulatory or other legal settings, or from external development partners. He/She maintains liaison with clinical research personnel in order to identify and meet the statistical support required by the development strategy under the supervision of the Associate Director or Director. He/She also contributes to the long-term growth strategy of the department by participating in process improvement initiatives, keeping abreast of the current statistical methodology development, and providing mentorship to new/junior biostatisticians.
1. Represent Biostatistics on Project Teams; provides statistical expertise to support clinical development objectives and strategy
2. Defines statistical methodology, analyzes data and reports results and contributes to the strategic planning and execution of the clinical development plan for the assigned project; trains and supervises contract statisticians and ensures the quality of their deliverables.
3. Assists responses to addressing statistical issues are part of regulatory, legal or other challenges to the company’s products or processes; may represent Biostatistics in key meetings as assigned
4. Serves as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel, and acts as an internal consultant, as assigned, on broad statistical issues that impact on the pharmaceutical/Biotechnology industry
5. Participates in approved process improvement initiatives; mentors new/junior biostatisticians; keeps up to date current on statistical methodology and computing development. Conducts modelling and simulations as needed.
- PhD in Biostatistics/Statistics or equivalent with a minimum of 3-4 years relevant work experience or MS in Biostatistics/Statistics with a minimum of 5-6 years relevant experience.
- Thorough understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.
- Ability to provide technical solutions to a wide range of difficult problems. Solutions are innovative, thorough and practicable, and consistent with objectives.
- Working knowledge of medical/biological terminology and clinical trial designs and competitive landscape in relevant therapeutic areas.
- Conversant with SAS or other software programming, and detailed knowledge of SAS procedures as well as computing tools for modelling and simulations.
- Working knowledge of regulatory guidelines and Commercial needs relating to statistical analysis, study reports and statistical components of regulatory submissions.
- Able to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change
- Able to write and present information effectively. Demonstrates leadership skills with effective communication including being able to explain methodology and consequences of decisions in lay terms; able to translate requests to meaningful and relevant hypotheses/statistical questions
The Principal Biostatistician is responsible for providing the statistical expertise for company products within one or more therapeutic areas, He/She participates in protocol development, analysis plans and file/report specifications, and reviews study setup activities including but not limited to randomization, CRFs and data edits and serves as lead biostatistician assigned project(s).