Plc programming serp_jobs.h1.location_city

Attention recruitment agencies : All agency inquiries are vetted through 4DMTs internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated and doing so may impact your ability to work with 4DMT in the future.

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Companys lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single safe intravitreal injection which substantially reduces the treatment burden associated with current bolus injections. The Companys lead indication for 4D-150 is wet age-related macular degeneration which is currently in Phase 3 development and second indication is diabetic macular edema. The Companys second product candidate is 4D-710 which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery

GENERAL SUMMARY

The Associate Director Statistical Programming provides technical leadership and operational oversight for statistical programming activities across multiple clinical development programs. This role is accountable for the accuracy quality and timeliness of programming deliverables for clinical trial reporting integrated safety / efficacy analyses and global regulatory submissions. The position also drives the development and maintenance of programming standards SOPs and tools and ensures compliance with CDISC standards ICH GCP and applicable regulatory requirements. The incumbent will collaborate closely with cross functional teams and external vendors and may manage and mentor programming staff.

MAJOR DUTIES & RESPONSIBILITIES :

Programming Leadership & Delivery

• Lead statistical programming activities for assigned programs including oversight of CRO deliverables.
• Develop review and execute SAS programs to produce SDTM / ADaM datasets tables figures and listings in accordance with SAPs.
• Perform quality control (QC) of programming deliverables to ensure accuracy consistency and compliance.
• Support ad hoc exploratory and postdoc analyses as needed.

Regulatory & Submission Readiness

Process & Standards Development

Cross Functional Collaboration

Team & Vendor Management

QUALIFICATIONS : Education :

Experience :

Other Qualifications / Skills :

Travel : 10%

Physical Requirements and Working Conditions :

Base salary compensation range : $185000 / yr - $227000 / yr

Please note the base salary compensation range and actual salary offered to the final candidate depends on various factors : candidates geographical location relevant work experience skills and years of experience.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race color religion gender sexual orientation national origin age disability genetic information marital status status as a covered veteran and any other category protected under applicable federal state provincial and local laws.

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

Required Experience :

Director

Key Skills

Program assessment,FDA Regulations,Manufacturing & Controls,Program Evaluation,budget forecast,Research Experience,Operations Management,Research & Development,Strategic Planning,Contract Management,Leadership Experience,negotiation

Employment Type : Full-Time

Experience : years

Vacancy : 1