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Kymera Therapeutics

Biotech company engineering targeted protein degraders

Associate Director or Director of Statistical Programming

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeWatertown, MA, USAIn-person

About the Job

Requirements

  • A master's degree or equivalent in Statistics, Biostatistics, Computer Science, or a related field; a bachelor's degree with substantial relevant experience will also be considered.
  • At least 8 years of statistical programming experience in the pharmaceutical or biotechnology industry, including experience supporting Phase I, II, and III clinical trials.
  • Demonstrated leadership of programming activities for a compound-level program and proven ability to influence across functions.
  • Experience overseeing CROs and external vendors, with accountability for quality, timelines, and deliverables.
  • Deep hands-on expertise with CDISC standards, including SDTM, ADaM, and Define-XML, and strong knowledge of regulatory submission requirements such as NDA/MAA and eCTD; prior experience leading or contributing to at least one successful submission.
  • Hands-on experience writing SDTM and ADaM specifications and setting up and managing in-house programming workflows and projects, including task allocation, validation, and quality control.
  • Advanced SAS programming proficiency and the ability to independently produce high-quality analysis datasets, tables, listings, and figures, including for ad hoc data requests.
  • Strong expertise in programming and analyzing efficacy endpoints and translating clinical objectives into analysis-ready datasets and outputs.
  • Ability to collaborate in cross-functional settings, adapt to a fast-paced or startup environment, and manage competing timelines and priorities while maintaining quality.
  • Ability to write efficient, well-organized, well-documented code and adapt to changing requests.
  • Proactive, solutions-oriented approach, with strong communication and leadership skills.

Responsibilities

  • Lead statistical programming for a compound-level program, including programming strategy, timelines, and resource planning, to ensure timely, accurate, and regulatory-compliant deliverables.
  • Partner with Biostatistics, Clinical Development, Data Management, Clinical Operations, and other cross-functional teams to align on timelines, priorities, and quality expectations.
  • Partner with the PK/PD function to manage the blinded data process during the double-blind period, ensuring role-based data access in line with the blinded data management plan.
  • Coordinate ongoing data review across programming, data management, and study team stakeholders, including data transfers and delivery of required outputs.
  • Oversee CROs and external vendors delivering SDTM, ADaM, and TLF outputs, ensuring technical quality, consistency, and clear documentation.
  • Manage in-house programming projects, including establishing and maintaining workflows for task assignment, validation, version control, and delivery, and overseeing in-house programmers.
  • Write SDTM and ADaM specifications, and develop, validate, and maintain datasets and TLFs to support data review, CSRs, publications, and ad hoc data requests.
  • Support regulatory submissions, including Define-XML, ADRG/SDRG, and eCTD, and provide documentation and expertise for audits and inspections.
  • Contribute to department standards, processes, and tools, including automation and AI-enabled tools, and mentor programmers as needed.
  • Perform additional duties and responsibilities as required.

Desired Qualifications

  • Experience supporting blinded data processes in double-blind studies.
  • Experience with R or Python.

About the Company

Kymera Therapeutics

Biotech company engineering targeted protein degraders

Kymera Therapeutics develops therapies that remove disease-causing proteins using targeted protein degradation. The company’s Pegasus Platform helps identify which proteins to degrade and then uses molecules that recruit the cell’s waste machinery to break down those proteins, aiming to treat cancers and immune diseases. This approach can create multiple drug candidates across different diseases. Kymera’s products are advanced through collaborations, most notably with Sanofi, which supports research, licensing, and milestone-based payments. Unlike traditional drugs that inhibit a protein’s function, Kymera’s strategy eliminates the protein itself, potentially offering new treatment options for patients. The company’s goal is to deliver new, effective medicines by degrading harmful proteins, expanding options in the biopharmaceutical market and addressing unmet medical needs.

Company size
201-500
Company stage
IPO
Headquarters
Watertown, MA
Founded
2016

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