Sr. Principal Biostatistician (Cambridge or RTP)

Key Skills

Biostatistics, SAS, Statistical modeling

Job Description

About this role

As the Senior Principal Biostatistician, you are 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, Biotherapeutic and Medicinal Sciences (BTMS) or Pharmaceutical Operations & Technology (PO&T). You act as independent Study Management Team (SMT) or Research and Development Project Team (RDPT) Biostatistician, provide statistical input in the scientific discussion, participate in protocol development, analysis plans and file/report specifications, and review study setup activities including but not limited to randomization, Case Report Forms (CRFs) and serve as lead biostatistician assigned project(s). You perform statistical analyses, interpret statistical results, and prepare clinical study reports including integrated summaries for submissions as appropriate. You also assist in preparation of responses to statistical issues arising in regulatory or other legal settings, or from external development partners. You maintain 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. You also contribute 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.

What you'll do

• Represent Biostatistics on Project or Study Teams; provides statistical expertise to support clinical, discovery, research, biomarker development, objectives and strategy.
• Define 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.
• Assist 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
• Serve 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
• Participate 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

Required skills:

• 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