My client a Growing Biotech, is Looking to Bring on a Dynamic and Experienced Director of Statistical Programming
Are you a seasoned statistical programmer with a passion for innovation and a knack for building high-performing teams? Do you thrive in a dynamic environment where you can make a tangible impact on the lives of others? If so, we encourage you to explore this exciting opportunity to lead our statistical programming function at a leading biotechnology company.
About the Biotech
They are a rapidly growing biotech company committed to developing groundbreaking treatments for debilitating diseases. Their team of passionate scientists and researchers is driven by a shared vision of improving the lives of patients worldwide. They foster a collaborative and supportive environment where individuals are empowered to make meaningful contributions.
About the Role
As their Director of Statistical Programming, you will play a pivotal role in shaping the future of their clinical programs. You will be responsible for developing and implementing programming strategies, overseeing programming activities, and building a team of exceptional programmers to support their expanding pipeline.
* Build out a team & lead/mentor a team of statistical programmers to support clinical trials and pipelines
* Develop and implement programming processes, standards, and SOPs to ensure data quality and integrity
* Effectively manage programming activities on projects and studies, including overseeing CROs
* Collaborate with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and other functions to deliver high-quality data deliverables
* Review and validate SAS programs for standard (SDTM, ADaM) and non-standard (custom study-specific) datasets and TFLs
* Develop SAS programming infrastructure and programming processes to enable efficient data deliverables and ad-hoc analyses
* Generate ad-hoc analyses on an ongoing basis
* A minimum of 10 years statistical programming experience coming from Direct Pharma
* Advanced SAS programming skills and experience in other statistical software, such as R, etc.
* In-depth knowledge of CDISC standards, including SDTM, ADaM, and controlled terminologies
* Excellent organizational and communication skills, with the ability to prioritize tasks and work effectively in a fast-paced environment
* Proven experience managing CROs and other data vendors
* Strong leadership skills, with a growth mindset, willingness to learn from others
* Ability to keep pace in a fast-moving organization and adapt to changes
* Advanced knowledge of state-of-the-art statistical programming methods in the clinical study setting
* Familiarity with ICH guidelines and FDA/EMA/other regulatory authority guidance
What We Offer
* Competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare, and retirement benefits
* Flexible PTO and generous paid time off
* Commitment to professional development and growth
* 100% remote work arrangement with regular in-person team meetings to foster connections and collaboration
Join Their Team and Make a Lasting Impact
If you are ready to take your career to the next level and join a company that is truly making a difference in the world, we encourage you to apply for this exciting opportunity.