- PhD in Biostatistics/Statistics or equivalent with a preferred 3+ years relevant work experience or MS in Biostatistics/Statistics with a preferred 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
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Senior Principal Statistician - Cambridge, United States - Biogen
Description
Job Description
The Senior Principal Biostatistician is responsible for leading study design and data analysis and providing the statistical expertise for company products within one or more therapeutic areas in clinical development. He/She act as independent SMT or RDPT Biostatistician, provides statistical input in the scientific discussion, participates in protocol development, analysis plans and file/report specifications, and reviews study setup activities including but not limited to randomization, CRFs 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.
Principal Accountabilities
1. Represent Biostatistics on Project or Study 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.
Qualifications
Who You Are:
You are an experienced biostatistician with a thorough understanding of statistical principles and clinical trial design/methods and with experience in submission or responding to regulatory questions and with proven ability to develop creative statistical/technical/regulatory acceptable solutions to complex problems in the design/analyses of clinical trials. You have leadership skills in effective communication, proactive strategy thinking, priority evaluations, and team working.
Qualifications:
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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