Associate Director/ Director SAS Programming at Adicet Bio

Redwood City, California, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Feb, 26

Salary

269000.0

Posted On

07 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

SAS Programming, Clinical Trial Data, Data Quality, Regulatory Compliance, Statistical Analysis, CDISC Standards, Leadership, Problem-Solving, Collaboration, Mentorship, Documentation, Biomarkers, Quality Control, Statistical Concepts, Drug Development Process, Communication

Industry

Biotechnology Research

Description

JOIN US! Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com. Associate Director / Director SAS Programming Adicet Bio is seeking an experienced Clinical Statistical SAS programmer responsible for developing, implementing, and validating SAS programs to analyze clinical trial data. This role involves creating analysis datasets, tables, listings, and graphs according to the statistical analysis plan, ensuring data quality and regulatory compliance. This individual will also lead programming activities, validate the work of other programmers, and act as a subject matter expert for their teams. They will work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of clinical trial analysis datasets and statistical outputs for study reports. The position will also support data management to prepare, execute, report and document data cleaning support deliverables for assigned projects by creating SAS programs to generate reports, detect protocol deviations, etc. Key responsibilities: Develop and validate SAS code: Write, test, and validate SAS programs to produce analysis datasets, summary tables, listings, and graphs from clinical trial data including Biomarkers. Adhere to standards: Ensure all programming activities comply with company Standard Operating Procedures (SOPs) and regulatory guidelines, such as ICH and CDISC (SDTM, ADaM). Lead programming activities: Provide leadership on programming projects, including managing timelines, resources, and the overall quality of deliverables. Create specifications: Develop and review programming specifications for datasets and outputs based on statistical and sponsor requirements. Quality control: Perform quality control checks on the work of other programmers to ensure accuracy and resolve any discrepancies. Collaborate internally with teams: Work closely with cross-functional teams, including clinical operations, statisticians, data managers, and medical writers, to ensure accurate data analysis and reporting. Provide status updates on programming tasks and get input needed to meet timelines. Mentorship and expertise: Mentor and train less experienced team members and serve as a subject matter expert on complex programming issues. Maintain documentation: Ensure all programming activities, testing, and verification are well-documented for inspection readiness. Statistical and Programming Input: Review and assist with Statistical Analysis Plans, Mock Shells, SDTM, ADaM Specifications, SAS Programs and outputs to confirm accuracy of documents and outputs including validation of primary and key secondary endpoints Collaborate externally with vendors and contractors by attending necessary meetings with external vendors. Managing CROs for timelines, adherence to their and Adicet SOPs and oversight of budgets for outsourced programming tasks. Qualifications and Expertise: Educational Qualification: Master's degree or higher in computer science, statistics, or related field Experience: 10+ years of SAS programming experience in a pharmaceutical or biotech environment of Phase 2 or 3 clinical trial data SAS proficiency: Strong programming skills in SAS, including experience with SAS macros, is essential. Clinical trial knowledge: Deep understanding of clinical trial methodologies, statistical concepts, and the drug development process. CDISC standards: Advanced knowledge of CDISC data standards, including SDTM and ADaM. Problem-solving: Excellent problem-solving abilities to address complex programming and data reporting challenges. Leadership: Demonstrated ability to lead projects, manage timelines, and mentor staff. Communication: Strong verbal, written, and interpersonal communication skills for effective collaboration. Pay Range $195,000—$269,000 USD Adicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite at least three days per week (Tuesday–Thursday mandatory), with some roles requiring full-time onsite presence. At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting autoimmune diseases and cancer. We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match. To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs. We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave. Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms. Adicet is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Responsibilities

The Associate Director/Director SAS Programming will develop, implement, and validate SAS programs to analyze clinical trial data, ensuring data quality and regulatory compliance. This role includes leading programming activities, validating the work of other programmers, and collaborating with internal and external teams.