Director, Statistical Programming

MDWerks Inc.

Director of Statistical Programming overseeing SDTM, ADAM datasets for clinical studies at Mineralys Therapeutics. Collaborating with teams to ensure quality data outputs and standards compliance.

Posted 5/27/2026full-timeRemote • 🇺🇸 United StatesLead💰 $235,000 - $248,000 per yearWebsite

About the role

Key responsibilities & impact

Accountable for all core SP deliverables (SDTM, ADAM, TFLs)
May also be accountable for clinical programming tasks (creation of SDTM and complex edit checks)
Provides ongoing data review by providing programmed edit checks, risk-based monitoring metrics, and draft TFLs
With IT, defines our programming environment and its validation
Responsible for the development of standards, SOPs, and best practices
The role is a combination of vendor oversight, supervision of more junior statistical programmers, and some hands-on work.
The Director SP will supervise assigned junior programmers, both contractors and regular staff members.

Requirements

What you’ll need

BS/BA degree and 10+ years of experience in analyzing clinical data OR
MS in statistics or related area and 7+ years of experience in analyzing clinical data.
Experience with FDA submissions and the provision of data submission packages
Experience in multiple areas outside of clinical development (e.g. pre-clinical, medical affairs, RWE)
Deep knowledge of the SAS programming language
Demonstrated accomplishments in automatization (usually through SAS macro development)
Working knowledge of at least one other programming language, preferably R
Experience with using genAI to create programming code or data processing algorithms.
Ability to work in an interdisciplinary team in a collaborative way
Represents biometrics in a positive and professional manner
Ability to work in a fast-paced team environment with fluctuating priorities
Common sense and solution-oriented mindset
Intellectual curiosity with a sense of pragmatic implementation of new ideas
Ability to communicate effectively in English, both orally and in writing.

Benefits

Comp & perks

Medical
Dental
Vision
Time off
401K
Participation in Mineralys incentive plans contingent on achievement of personal and company performance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

SAS programmingR programmingdata analysisSDTMADAMTFLsedit checksdata submission packagesautomatizationgenAI

Soft Skills

collaborationcommunicationproblem-solvingadaptabilityleadershipinterpersonal skillsintellectual curiositysolution-oriented mindsetprofessionalismteamwork

Certifications

BS/BA degreeMS in statistics