Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has entered into a strategic partnership with BeiGene, Ltd. for the rights to develop DKN-01 in Asia (excluding Japan), Australia, and New Zealand. Leap has a strong financial position and in September 2021 closed a public offering with gross proceeds to Leap of approximately $104 million. Leap is based in Cambridge, MA. For more information about Leap Therapeutics, visit https://www.leaptx.com.
Associate Director Statistical Programmer is responsible for leading and managing all aspects of statistical programming activities from study inception to the creation of the Clinical Study Report, across multiple Oncology studies in Phases I-III. The incumbent will collaborate closely with Biostatistics, Clinical Data Management, Regulatory, Clinical Development, Clinical Operations, Drug Safety, Bioanalytics, and other functions to provide programming support and influence the clinical development process.
Specific Responsibilities Include:
- Oversees Statistical Programming activities performed by CROs and consultants. Act as project manager for statistical programming deliverables ensuring that the deliveries are per the agreed timelines and quality.
- Reviews and provides input into study protocols, database modifications, CRFs, Statistical Analysis Plans (SAPs), Mock Table Shells, study TFL output and Clinical Study Reports as directed.
- Leads/contributes to the review of specifications for SDTM and ADaM datasets as well as define.xml, annotated CRF, study reviewers guide documents.
- Leads the assessment and performs quality control checks/validation of SAS code and output produced by CROs, vendors or other Statistical Programmers for SDTM datasets, ADaM datasets, and TFLs.
- Performs ad hoc programming reports for exploratory analyses, publications, posters, and presentations, in a timely and high-quality manner, as needed.
- Collaborates with internal Data Management personnel to develop data cleaning listings, external vendor data checks and best practices surrounding data storage, maintenance, retrieval, and data integrity.
- Leads/contributes to Biometrics infrastructure development projects and drives automation initiatives to build operational efficiency.
- Drives adherence to organizational standards and regulatory guidelines (e.g., FDA, ICH, etc.).
- Participate in internal study team meetings as well as teleconferences with vendors and study personnel.
- Support program level activities for DSUR, Safety Signaling, IB and Annual Reports.
Education / Experience / Skills:
- MS in Statistics, Computer Science, or a related field with at least 8 years (or BS in Statistics, Computer Science, or a related field with at least 10 years) of SAS programming experience in the pharmaceutical or biotech industry
- Strong hands-on SAS programming skills. Familiarity with R is a plus.
- Experience with oncology studies preferred.
- Small biotech experience a plus.
- In-depth knowledge of CDISC standards for SDTM and ADaM, Controlled Terminology and FDA electronic data submission requirements.
- Demonstrated ability to manage CRO relationships and consultants; oversee programmed deliverables.
- Familiar with statistical analysis methods and clinical data management concepts.
- Working knowledge of and experience with FDA regulations and ICH GCP guidelines. Familiarity with industry best practices.
- Proven experience of independently leading statistical programming activities for regulatory submissions.
- Proven ability in developing programming specifications, integrated summary safety/efficacy datasets and analysis, electronic submission data package in the eCTD format.
- Capability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change, in a fast-paced, small company setting.
- Strong interpersonal, documentation and communication skills are imperative (verbal and written).
- Excellent attention to detail.
- Good organizational and time management skills.
- Amenable to occasional travel (up to 10%).
Leap is an equal opportunity employer and extends equal opportunity to all individuals, without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic disposition, caregiver status, reproductive health decisions, status as a victim of domestic violence, sexual violence or stalking, credit history, criminal history, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. We are committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives.