Associate Director Statistical Programming
Associate Director Statistical Programming
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$ 170000 - 210000
1 Vacancy
Job Description
About Allogene:
Allogene Therapeutics with headquarters in South San Francisco is a clinicalstage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy Allogene is developing a pipeline of offtheshelf CAR T cell product candidates with the goal of delivering readily available cell therapy ondemand more reliably and at greater scale to more patients. For more information please visit www.allogene and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.
About the role:
The Associate Director Statistical Programming will lead and oversee the clinical trial analysis and reporting of assigned project(s). This position oversees the statistical programming deliverables of assigned projects to ensure that the assigned clinical development programs meet scientific regulatory and quality requirements and are aligned with longterm development goals. This position is expected to ensure the team members contribute to required programming deliverables for the assigned projects/studies that are aligned to the organizational goals and building innovative statistical programming tools and applications.
Responsibilities include but are not limited to:
- Technical lead and project manager for assigned project(s) managing multiple aspects of the study deliverables related to statistical programming.
- Represent the statistical programming at Study Management Team to address deliverables and timelines.
- Assist in the review of key studyrelated documents produced by other functions e.g. SAP case report form data management plan database specifications EDC data structures DMC plans and other clinical documents.
- Interact and communicate with Statisticians Data Managers Clinical Operations Medical Monitors Medical Writing and Medical Monitors to address programming related study deliverables
- Write test and validate SAS programs to produce analysis datasets TLGs and presentation output to be included in reports for submission to regulatory agencies publications and other communications as needed.
- Understand and execute department product and studylevel macros and utilities. Write test and validate product and studylevel macros and utilities
- Develop review and provide guidance on SDTM/ADaM specifications.
- Be a technical resource for a programming team and able to provide advice on programming tasks or standards.
- Contribute to development of statistical programming policies procedures and other controlled documents.
- Interface with outsourcing partners and vendors.
- Provide managerial support with overall responsibility of leading training and mentoring for effective performance.
- Support SAS and other analytic system implementation and maintenance
- Other duties as assigned.
Position Requirements & Experience:
- Bachelors or Masters degree in Computer Science Statistics Mathematics Life Sciences or other relevant scientific subject.
- 5 years experience in lead statistical programming role of clinical trial data with a biotech or pharmaceutical company.
- Expert level SAS programmer with experience in delivering on complex programming assignments and analysis
- Strong background in using MS Excel and SharePoint management.
- Strong knowledge of CDISC standards is required.
- Experience in Oncology Trials.
- Experience in FDA/EMEA regulatory submissions.
- Demonstrated ability to assess information make timely decisions and prioritize numerous tasks.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- Candidates must be authorized to work in the U.S.
We offer a chance to work with talented people in a collaborative environment and provide a topnotch compensation and benefits package which includes an annual performance bonus equity health insurance generous time off (including 2 annual holiday companywide shutdowns) and much more. The expected salary range for this role is $170000 to $210000. Actual pay will be determined based on experience qualifications geographic location business needs and other jobrelated factors permitted by law.
As an equal opportunity employer Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin gender age sexual orientation physical or mental disability genetic information or characteristic gender identity and expression veteran status or other nonjobrelated characteristics or other prohibited grounds specified in applicable federal state and local laws. We also embrace differences in experience and background and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing lifechanging products for patients.
#LIEL1 #LIREMOTE
Required Experience:
Director
Employment Type
Full-Time
