The OpportunityReporting to the Head of Biometrics, this individual will contribute to daily statistical activities and support the development of statistical approaches for clinical trials. Working closely with internal and external stakeholders, you will help manage a growing portfolio of trials. This role also offers the opportunity to support the continued growth of the biostatistics function at Entrada and gain valuable experience in a collaborative, fast-paced environment.
Responsibilities- Support statistical strategy for assigned drug programs, including input to clinical development plans, clinical study concepts and protocols design, SAPs, clinical study reports, regulatory documentation and associated publications.
- Accountable for oversight of the production of biostatistics deliverables (TFLs, including planned, post-hoc, and/or exploratory analyses) as performed by external resources.
- Provide statistical strategy support and input in protocols, CSRs, and scientific presentations and manuscripts.
- Review the randomization procedures and oversight of the production of randomization lists.
- Review study Case Report Forms, data management plan and other data management related documentation to ensure that specific statistical requirements defined in the study protocol are met.
- Oversee outsourced statistical CRO activities and deliverables, ensuring high quality and timely delivery.
- Produce innovative tools and methodologies for statistical analysis through literature review.
- Participate in the development of department strategies and cross functional initiatives on standards, infrastructure, and processes.
The NecessitiesAt Entrada, our passion for science, our devotion to patients and our values drives our behavior:
- Humanity - We genuinely care about patients and about one another.
- Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
- Creativity - We are creative problem solvers.
- Collaboration - We are more than the sum of our parts.
- Curiosity - We have a growth mindset and push conventional thought and theory.
To thrive on our team, you will need to come with:
- Ph.D. in Statistics or a related field, with 6 + years of experience in statistical analysis within the biotech/pharmaceutical industry.
- Experience with a broad array of statistical approaches and experience in proposing novel approaches to support acceleration of clinical programs. Knowledge in the latest developments in the analytical world including machine learning and artificial intelligence is a plus.
- Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical practice.
- Strong statistical programming skills (R, SAS, Python).
- Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications.
- Strong vendor management experience.
- Previous experience in Neuromuscular, Ophthalmology or related TA is preferred.
- Excellent verbal and written communication skills, coupled with strong attention to detail and proactive mindset.
- This is a US based remote position, with preference given to local New England based candidates. This role will require a minimum quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA. #LI-JF1 #LI-Remote
What We Offer: Meaningful Work, Fair Rewards, and Real SupportAt Entrada Therapeutics, we understand that compensation and total rewards are a major consideration when exploring a new opportunity. We believe in transparency and equity and are committed to sharing salary ranges for every position, along with insight into our compensation philosophy, in accordance with certain state requirements in the United States and fostering a fair and open environment at the onset.
But we also know it is more than just pay. When you join Entrada, you'll be part of a mission-driven team with access to comprehensive health, dental and vision coverage; life and disability insurance; with a 401(k) match. We pride ourselves on offering competitive benefits that empower our employees and reflect the value of their contributions - offering paid, gender-inclusive parental leave, holistic support for your health and well-being, education reimbursement, discretionary time off and commuting benefits aligned to your working model. If you find yourself working from our office in Boston's Seaport District, this puts you steps away from some of the best the city has to offer.
"Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. At Entrada, we know that meaningful work deserves meaningful reward - and we view compensation as one way we show appreciation for the collaboration, curiosity and commitment that drive our mission forward."
- Kerry Robert, SVP of People
The salary for this opportunity ranges from $203,000-$247,000. The final base compensation offered will depend on several considerations which include but may not be limited to a candidate's skills, competencies, experience and other job-related factors permitted by law. The final salary offered may fall outside of this range.
