Senior Manager, Statistical Programming
Company: 4D Molecular Therapeutics
Location: Emeryville
Posted on: January 27, 2026
|
|
|
Job Description:
Attention recruitment agencies: All agency inquiries are vetted
through 4DMT’s 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
Company’s 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
Company’s 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 Company’s 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 Sr Manager, Statistical Programming
provides technical leadership for statistical programming
activities for a given clinical development program. 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 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. 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
post?hoc 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 reviewer’s guides (SDRG, ADRG). Process & Standards
Development 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 non?technical stakeholders.
Team & Vendor Management Participate in CRO selection, contracting,
and performance evaluation. Ensure vendor deliverables meet agreed
timelines, quality standards, and contractual obligations.
QUALIFICATIONS: Education: Master’s or PhD in Statistics,
Biostatistics, Mathematics, Computer Science, or related field (BS
with significant experience considered). Experience: 7 years of
statistical programming experience in pharmaceutical, biotechnology
industry w/ Bachelors. 4 years w/ Masters. 3 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
reviewer’s 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, problem?solving,
and project management skills. Ability to manage multiple
priorities in a fast?paced, 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: $154,000 - $179,000 Please note, the
base salary compensation range and actual salary offered to the
final candidate depends on various factors: candidate’s
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
Keywords: 4D Molecular Therapeutics, Manteca , Senior Manager, Statistical Programming, Science, Research & Development , Emeryville, California