Principal / Lead Biostatistician
Proclinical is currently recruiting for a Principal/Lead Biostatistician with a leading biopharmaceutical company located in San Francisco, CA. Successful candidate will serve as a lead statistician on clinical studies and provide senior level statistical input to BDM department.
- Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
- Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Ensure budgets, schedules, and performance requirements are met. Regularly interact with senior management or executive-levels.
- Communicate with various internal and external audiences such as, scientists, engineers, clinicians, quality staff and partners as required.
- Provide strategic input on protocol design and clinical trial data analysis, develops statistical analysis plans and statistical methodology sections of planned protocols, oversight of programming support and of any outsourced biometric responsibilities.
- Provide a statistical interface with Regulators, craft responses to relevant Regulatory questions, provide assistance in the generation of high-quality clinical trial data to aid in programmatic decision-making.
- Play a statistical leadership role in the support of Regulatory filings and submissions. Contribute to the development of charters for DSMBs and Endpoint Adjudication Committees and may serve as a sponsor liaison with these committees.
- Manage the development, review and approval of relevant SOPs, and CRF design.
- Ensure adequate procedures and processes are in place for the biostatistics group and that data set and analyses are stored according to established company policies and all relevant regulatory mandates.
- Prepare and provides written reports, presentations and publications as required. Collaborate with other functional lines including Regulatory, Clinical Sciences and Clinical Operations.
- Serve as point of contact for biostatistical support and data management services provided by external vendor.
- Identify, develop and deliver internal biostatistics training courses as required. Manage the utilization of resources and identify when and where additional resources may be needed to provide effective biostatistics support to customers.
- Responsible for providing regular performance feedback, development and coaching to direct reports.
Skills and Requirements:
- Bachelor's degree in a statistics discipline is required. An advanced degree in a statistics discipline is strongly preferred.
- 10+ years' experience in statistics related to the pharmaceutical industry is required.
- A minimum of 8 years previous management experience is preferred. Previous experience working in a quality regulated environment with a thorough understanding of cGCPs is highly preferred.
- Must have a thorough understanding of SAS programming.
- Must be able to demonstrate expert knowledge of statistical principles and concepts. Must be able to demonstrate strong project management skills.
- Previous experience designing and delivering presentations/trainings is required.
- Strong oral and written communication skills are required.
- Experience working in a team-focused environment is preferred.
- Excellent computer skills are required.
- Must have an ability to create and manage internal and external technical and business relationships, representing the company in a highly professional manner.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Felix Hook at (+1) 646-367-2617 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.