Remote Associate Director, Statistical Programming

Definium Therapeutics, Inc.

New York, Northern (NY, KY)

Hybrid

USD 155,000 - 195,000

Full time

4 days ago

Be an early applicant

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

Benefits offered by this job

Health benefits

401(k) with company match

Flexible time off

Parental leave

Job summary

Definium Therapeutics, Inc. invites an Associate Director, Statistical Programming to provide expert statistical programming support across clinical development, regulatory filing, and commercialization.

You will act as the study lead programmer for assigned trials, collaborating with biostatisticians, data management, and vendors to ensure high-quality results on schedule. This role requires mastery of CDISC standards, Define XML, and SDTM/ADaM datasets, with oversight of external vendor

Qualifications

Master's Degree in Biostatistics, Statistics, Computer Science or related field with at least 12 years' clinical trial statistical programming experience.
Expertise with SDTM/ADaM datasets, Define XML, and regulatory submission packages.
Proficient in SAS and clinical data standards; able to lead programming activities in late-stage trials.

Responsibilities

Serve as study lead programmer for assigned clinical trials and coordinate with statisticians and data management.
Review Define packages and CDISC-compliant datasets for regulatory submissions.
Ensure high-quality outputs and timely delivery through vendor coordination and QC.
Perform independent validation of analytic outputs and data management handoffs.
Support publication activities and regulatory communications as needed.