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Associate Director, Statistical Programming
3 months ago
At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.
We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future.
Position Summary: Reporting to Sr. Director of Statistical Programming within the Biometrics Department, Associate Director of Statistical Programming is expected to be a highly experienced functional area project leader with expert knowledge of Statistical Programming strategy, concepts and processes, excellent programming skills and capabilities in overseeing Statistical Programming activities in accordance to company and departmental processes and procedures.
Key Duties and Responsibilities:
- Responsible for providing technical leadership for Statistical Programming activities on assigned studies.
- Collaborate closely with Biostatistics, Clinical Data Management, Clinical Operations, and other functions to provide programming support as needed.
- Act as a Programming Subject Matter Expert on assigned studies, including generation or validation of SDTM and ADaM datasets, as well as producing Tables, Figures, and Listings as needed.
- Provides programming support for DSUR, IB, publications, posters, and presentations in a timely and high-quality manner.
- Oversees Statistical Programming deliverables provided by service providers on assigned studies.
- Serves as the statistical programming primary point of contact for a given program or across various programs and studies, representing the Statistical Programming on the clinical team for cross-trial activities as needed.
- Contributes to the development and maintenance of departmental policies, procedures, training, and standards.
Requirements
Qualifications:
- Bachelor’s or advanced degree (Masters, PhD) and/or equivalent in computer science, mathematics, or other relevant scientific field e.g. Biology/Pharmacology (or equivalent theoretical/technical depth).
- Approximately 10+ years programming experience with increasing responsibility OR Masters (or equivalent) in a relevant field and 8+ years relevant experience in a pharmaceutical/ clinical trial environment.
- In-depth knowledge of programming practices and concepts (including tools, languages, and processes) and relevant regulatory guidelines policies.
- In-depth knowledge of CDISC SDTM/ADaM standards and FDA electronic data submission requirements. NDA/MAA/BLA submission experience preferred.
- Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL. Familiarity with R is a plus.
- Demonstrable experience in developing SDTM, ADaM, Define XML and Reviewer’s Guide as per the CDISC specifications.
- Capability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change, in a fast-paced, small company setting.
Benefits
Benefits Summary:
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.
