Provide statistical input to the creation of clinical development plan for the assigned compound(s)
Collaborate with cross-functional experts on clinical trial designs and make contributions to determination of objective, endpoints and sample size
Play as an integral part of a protocol development team by authoring statistical methods section and reviewing the protocol throughout
Ensure the accuracy of randomization algorithm and contribute to eCRF design to ensure data collection’s alignment with study objectives
Be the primary owner of study statistical analysis plan (SAP) for the assigned clinical trials alongside the shells for table/figures/listing (TFL) that present the analytic results and reflect the analysis intent specified in the SAP
Hold the primary responsibility of working with statistical vendors to implement the SAP and deliver study results with quality and speed
Hold the primary responsibility of managing statistical vendors to deliver other data analyses as needed (e.g., DMC support, interim analysis)
Provide statistical input to any form of data reporting or external dissemination, including clinical study report, regulatory communication and publication
Conduct data analyses as needed by using own SAS programs in collaboration with Statistical Program group for validation
Contribute to the development of Biometrics’ SOPs

A PhD degree in Statistics or Biostatistics with at least 10 years’ working experience in pharmaceutical or biotechnology companies
Solid statistical knowledge and experience in clinical trial design from early to late phase, data analysis and reporting
Strong track record using statistical methods to solve real problems emerged in clinical trials and resulted in right decision-making and/or compound advancement
Rich experience is authoring study SAP and TFL shells and driving the review process to achieve consensus among review functions to deliver the final versions of high quality
Extensive experience in managing statistical vendors to implement SAP and deliver study results with quality and speed
Solid knowledge and extensive experience of using statistical computational languages, such as SAS, to perform data analysis
Working knowledge of regulatory guidance relevant to clinical trials from design to analysis
Demonstrated capacity of collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Data Science and other relevant functions to deliver common goals
Strong organizational and project management skills; demonstrated interests of continued learning and growing
Detail-oriented and hold high standards of excellence for own work products
Deliver and communicate effectively in the work-from-home environment
Excellent interpersonal skills and is a good team player

100% paid health benefits including Medical, Dental and Vision for you and your dependents
401(k) program with company match and vesting after the turn of the first month after your start date
Flexible time off
Generous parental leave and some fun fringe perks!

Director, Biostatistics

Key skills