- Lead and manage the statistical programming activities for clinical trials and studies, ensuring high-quality deliverables and adherence to timelines
- Collaborate with biostatisticians, data managers, and cross-functional teams to define programming strategies and requirements
- Develop, validate, and maintain analysis datasets (CDISC standards), tables, listings, and figures, TLFs) in accordance with regulatory guidelines and internal standards
- Review statistical analysis plans (SAPs) to provide feedback and strategy to the team to execute the plans
- Perform complex statistical analyses and simulations using SAS, and R, to support clinical trial design and data interpretation
- Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD)
- Build and maintain software agnostic solutions/macros to automate repetitive tasks.
- Provide novel solutions to the Biometrics and cross-functional teams to better understand the data
- Mentor and provide guidance to junior programmers, ensuring their growth and development within the team
- Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis
Education and Skills Requirements: - Bachelor's or advanced degree in statistics, biostatistics, computer science, or a related field
- Minimum of 8 years of experience in statistical programming within the pharmaceutical or biotech industry
- Proficiency in SAS and R is essential; experience with Python is desirable
- Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements for clinical trials
- Demonstrated leadership and project management skills, including the ability to lead cross-functional teams
- Excellent communication and interpersonal skills
- Detail-oriented with a commitment to data accuracy and quality
- Ability to adapt to changing priorities and manage multiple projects simultaneously
#LI-Onsite
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. -
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Associate Director, Statistical Programming - Waltham, United States - Dyne Therapeutics
Description
Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).
Role Summary:
The Associate Director, Statistical Programming is accountable for program specific statistical programming activities and oversight related activities by vendors in clinical development, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. In collaboration with cross functional stakeholders, this position contributes to process optimization and innovation for clinical development. This position serves as the program team point person for statistical programing and data standards, provide consultation to the program teams, and be responsible for building a statistical programming team to support the Dyne clinical portfolio. This role assists the Head of Statistical Programming to contribute to departmental strategies and helps to drive the development and continuous improvement of departmental procedures, training, and standards.
Primary Responsibilities Include:
