Denovo Biopharma LLC is a clinical-stage biotechnology company that employs novel and proprietary biomarker discovery methodology to advance drug development. Our primary strategy is to rescue promising therapies in oncology and central nerve system (CNS) diseases by defining biomarkers that identify patients who would most likely benefit from these treatments. Several investigational drugs are in different phase clinical trials.
Reporting to the Head of Biostatistics, the Associate Director/Director of Statistical Programming will function as the leader of the statistical programming team, responsible for providing statistical programming supports to all clinical development programs at Denovo. In addition to work as a hands-on programmer for various internal requests, this individual will also need to direct, guide, and validate CRO programming team or internal consultants’ programming work, and work collaboratively with internal and external teams in results reporting and regulatory submissions.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- Lead and manage statistical programming activities for clinical studies, ensure statistical programming deliverables are delivered within timelines and with high quality and cross-study consistency.
- Represent statistical programming function in cross-functional study teams and collaborate with study teams to establish project timelines.
- Ensure CRO statistical programming deliverables are accurate, complete, and compliant with CDISC standards by reviewing CRO deliverables and perform acceptance check and validation.
- Perform hands-on programming to generate TFLs to support ad hoc requests and decision making.
- Review data management documents (such as CRF specification, data transfer agreements, data management plan, annotated CRF), SDTM specification, ADaM specification, Statistical Analysis Plan, and TFL shells to provide statistical programming feedback; perform other tasks as needed, including UAT of clinical databases, in support to the data management and operation teams.
- Lead statistical programming efforts in regulatory submissions and post-submission responses.
- Identify, develop and maintain statistical programming standards, processes, and SOPs.
- Bachelor’s or more advanced degree in statistics, computer science or other relevant scientific field. Master’s degree and above preferred.
- Minimum of 8 years of experience in statistical programming and statistical analysis of clinical trial data in pharmaceutical/biotech industry.
- Minimum of 3 years of experience as a lead statistical programmer or a programmer manager.
- Experience of NDA/BLA submission preferred.
- Experience of CRO oversight preferred.
- Demonstrated proficiency and expertise in SAS programming for data analysis in clinical trials.
- In-depth knowledge of programing practices and concepts, and relevant regulatory guidelines.
- Extensive knowledge of CDISC standards and Pinnacle 21 validator.
- Demonstrated expertise in creating and reviewing ADaM/SDTM specification.
- Broad knowledge in data collection, monitoring, cleaning, and analysis throughout clinical development.
- Ability to manage multiple projects in a fast-paced environment.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.