Search Jobs

Sr. Biostatistician- PT initially

Fairfield, CT

Posted: 09/19/2024 Job Number: 5775

Job Description

Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com
No 3rd party candidates
Part time for first few months and then will move into full time hours
Primary Responsibilities

-Provides support for all activities related to clinical development, including development of key study and program hypotheses, clinical development plans, study designs, regulatory meetings, submissions, and follow up.
-Applies innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design, and/or Bayesian approaches)
-Ensures accurate, statistically valid deliverables in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents.
-Coordinates simultaneous achievement of major statistical deliverables and milestones for multiple clinical trials across the portfolio in collaboration with the clinical development team and other functions
-Leads and manages internal/external biostatistics resources supporting studies and programs. Collaborates with data management and statistical programming to provide timely and accurate biostatistics deliverables.
-Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines
-Responsible for providing statistical input and leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
-Collaborates with Data Management and Statistical Programming to build our internal capabilities and develops standard processes for CDISC compliant data sets (SDTM and ADaM), performing formal tables, listing & figure production and QC in preparation for submission readiness.


Experience:

-Candidates need a PhD in Biostatistics/Statistics or with a minimum of 5 years pharmaceutical industry experience or MS in Biostatistics/Statistics with a minimum of 7 years pharmaceutical industry experience.
-Extensive experience with IND/NDA activities and regulatory interactions, including filing, ISS and/or ISE experience.
-Experience with interim analysis design, conduct and manage/support data monitoring committee.
-Excellent SAS programming and analytical skills to develop programs to QC, using SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macros. Ability to do simulations in a programming language such as SAS or R.
-Knowledge of GCP/ICH guidelines for conducting clinical trials
-Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially the FDA
-Effective communicator: able to explain methodology and consequences of decisions in lay terms; able to understand requests for complex analyses, etc.
-Able to manage multiple projects and conflicting priorities, and to be flexible when priorities change
-Effective team player with willingness to go the extra distance to deliver results, meet/exceed deadlines, etc.

Nice to have: Machine Learning using R and/or Python; experience in an agile environment.

Meet Your Recruiter

Terra Parsons
Director, Biometrics Recruitment

Terra is a Senior Recruiter with 19 years of experience in the pharmaceutical industry. She is driven by a passion for comprehensively understanding the needs of both clients and candidates, and adeptly matching them with opportunities that align with their needs and interests. Her specialization lies in biometrics recruitment, with a focus on sourcing top talent in roles such as statisticians, SAS/statistical programmers, and data managers. Her track record speaks volume about her ability to deliver high-quality candidates and exceed client expectations. In her free time, she enjoys spending time with her family, traveling, and fitness. 

 
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Fairfield, CT

Ready to take your career to new heights? Explore job opportunities in beautiful Fairfield, Connecticut, where coastal charm meets bustling city life. This vibrant area offers a perfect blend of picturesque beaches, historic landmarks like the Fairfield Museum, delectable local cuisine, and a thriving arts scene including the Regina A. Quick Center for the Arts. With proximity to New York City and easy access to outdoor recreational activities at places like Lake Mohegan, Fairfield is an ideal location for professional growth and work-life balance. Don't miss out on the chance to join this dynamic community – browse our job listings today!
Search Jobs
Request Talent
Blog
Contact Us