Sr. Biostatistician - REMOTE

A bit about us:Our client is a contract research organization, a type of organization that plays a vital role in the development of new treatments and medications for patients. They specialize in a variety of therapeutic areas including Transplants, Oncology, Rare Disease & Cell & Gene Therapy.Why join us?In addition to PTO, company-paid holidays, medical, dental and vision insurance our client also boasts the following! Our client has a structured mentoring program to provide the support you need to move forward Our client provides tuition reimbursement and partners with universities and colleges to create programs in our field, and have a dedicated training department Our client has never had a layoff in our 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade Our client has received multiple awards recognizing it as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry Our client has consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride itself on our average 95% annual retention rate Annual Target bonus 3+ weeks PTO Company credit card for travel expensesJob DetailsJob Purpose / SummaryRepresent Biostatistics on study teams, report study status to Biostatistics management, and perform, or oversee the performance of, all Biostatistics-related activities while ensuring the integrity of the data and analysis by adhering to all applicable regulatory requirements and Standard Operating Procedures (SOPs). What You'll DoAssist with the development and modification of department SOPs and work instructionsAssist with training new Biostatistics employees; mentor and assist junior level BiostatisticiansDevelop study bids and changes in scope for Biostatistics tasks in response to prospective client's request for proposals (RFPs).Attend and present the Biostatistics study execution tasks at capabilities presentations.As the lead Biostatistician on the studies to which you are assigned, perform or oversee the following tasks:Act as primary statistical contact for internal and external project team members.Manage projects to ensure statistics tasks are performed within the entire project timeline. Keep Biostatistics management aware of changes to project timelines.Proactively identify and communicate changes in scope to the clinical project manager and Biostatistics management.Review case report forms (CRFs) and completion instructionsGive input to database design and data edit considerations necessary to collect and clean dataDevelop or review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocolDevelop or review program specifications - SDTM and ADaM dataset specifications and mock tables, listings and figures (TLFs) - needed to perform the analysis defined in the IAP/SAPPerform the statistical analysis by independently programming derived datasets and TLFs and validate the developer's corresponding programs per department SOPsReview programming of other team membersDevelop or review statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications Plan and design clinical studies, including:overall study design developmentoutcome / endpoint determinationpower analysis / sample size estimation reportsrandomization and blinding procedures developmentstatistical methods section development in the protocolDevelop or review Randomization Plans and randomization programs or listsCarry out all activities according to SOPs and project-specific conventions within the framework of Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelinesRely on instructions and Biostatistics SOPs to ensure timely, standard, quality deliverables to customersMaintain accurate records of all work performed and ensure all relevant statistics documents are filed in the eTMF per the project-specific eTMF PlanProvide input to and participate in departmental meetingsWhat You'll BringMinimum of 4 years of related biostatistics experience in either a pharmaceutical or CRO environment or other relatable statistical experienceMaster's degree in Biostatistics, Statistics or related fieldCDISC SDTM and ADaM dataset mapping experienceBLA/NDA Submission experience; regulatory representation (i.e., meeting preparation/attendance, follow-up with regulatory communication) preferredTherapeutic experience in transplantation, autoimmune diseases, kidney and liver disease, oncology and rare disease preferredProvide statistical consulting to internal/external clients; review senior level statistics work preferred