Job Level: FSP Principal Biostatistician, Medical Affairs
Location: Home-based in the U.S. or Canada
Job Summary:
The Principal Biostatistician is responsible for providing statistical analysis support for pharmaceutical research in Phase 2 and 3 clinical trials.
Additional Benefits:
· Home-based remote working opportunities.
· Work/life balance as well as flexible schedules.
· Collaborating with motivated, high-performance, statistical and research teams.
· Technical training and tailored development curriculum.
· Research opportunities that match your unique skillset.
· Promising career trajectory.
· Job stability: long-term engagements and re-deployment opportunities.
· Focus on bringing new therapies to market rather than project budgets and change orders.
· Experience with regulatory submissions.
· Engaging, fast-paced environment.
· Good work-life balance.
Job Responsibilities:
· Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
· Author statistical analysis plans.
· Collaborate with Biostatistics, Statistical Programming, Clinical Development, and Clinical Operations to provide statistical expertise.
· Contribute to publications and presentations.
· Provide guidance and supervision to programmers in planning and execution of analysis.
· Independently program or validate statistical outputs (tables, listings and figures) using SAS or R
· Interpret study results and review reports of study results for accuracy.
· Support exploratory analyses.
Qualifications (Minimal acceptable level of education, work experience, and competency)
· PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
· MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
· At least 3 years in Phase 2/3 clinical trial experience.
· Demonstrated ability to work proactively and independently in a fast-paced environment.
· Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
· Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary.
· Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
· Experience with CDISC, including SDTM, ADAM, CDASH
Desired Experience:
Contributing to peer-reviewed publications and presentations.
#LI-Remote
#LI-NITINMAHAJAN
The potential base pay range for this role, when annualized, is $111,000.00 - $309,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
