Associate Director, Statistical Programming

Emeryville, CA - USA

Monthly Salary: Not Disclosed

Posted on: 7 days ago

Vacancies: 1 Vacancy

Job Summary

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

Prepare and standardize data packages for regulatory submissions (BLA NDA MAA) including ISS/ISE deliverables.
Ensure CDISC compliance using implementation guides and validation tools (e.g. Pinnacle 21).
Review and approve dataset specifications output shells and reviewers guides (SDRG ADRG).

Process & Standards Development

Develop and maintain programming SOPs guidelines macros and reusable tools.
Contribute to process improvement and standardization initiatives within the Biometrics function.
Stay current with evolving regulatory requirements industry standards and emerging technologies.

Cross Functional Collaboration

Represent Statistical Programming in internal and external meetings.
Partner with Biostatistics Data Management Regulatory and Clinical teams to align deliverables and resolve issues.
Communicate technical concepts clearly to both technical and nontechnical stakeholders.

Team & Vendor Management

Manage internal programming resources and mentor junior staff.
Participate in CRO selection contracting and performance evaluation.
Ensure vendor deliverables meet agreed timelines quality standards and contractual obligations.

QUALIFICATIONS:

Education:

BS in Statistics Biostatistics Mathematics Computer Science or related field with significant experience required.
Masters or PhD preferred.

Experience:

9 years of statistical programming experience in pharmaceutical biotechnology industry w/ Bachelors. 7 years w/ Masters. 4 years w/ PhD
Expert proficiency in SAS (Base Macro Stat Graph ODS); working knowledge of R or Python preferred.
Deep knowledge of CDISC SDTM/ADaM standards metadata and regulatory submission requirements.
Experience with Pinnacle 21 and preparation of reviewers guides.
Strong understanding of clinical trial design data collection and reporting processes.
Experience in Gene Therapy
Experience in ophthalmology preferred

Other Qualifications/Skills:

Excellent communication problemsolving and project management skills.
Ability to manage multiple priorities in a fastpaced matrixed environment.

Travel: 10%

Physical Requirements and Working Conditions:

Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists hands and/or fingers. Fingering: Picking pinching typing or otherwise working primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift carry push pull or otherwise move objects including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

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

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 tolera...