Senior Principal Biostatistician

Company Description

HI-Bio, Inc. is a Biogen company based in South San Francisco, California. As of July 2, 2024, we are part of Biogen’s global team, with a commitment to excellence and a pioneering spirit. As part of a mid-sized biotechnology company, we offer 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.

Our team in San Francisco is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.

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, biomarker development, research, BTMS or PO&T. 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.

Qualifications

• 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.
• 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.

Additional Information

The base compensation range for this role is $136,000 - $197,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.

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 build