Principal Biostatistician Position Available In Suffolk, Massachusetts

Job Description:

The Organization What’s happening at Entrada Therapeutics?

Entrada is a clinical-stage biopharmaceutical company aiming totransform the lives of patients by establishing a new class ofmedicines that engage intracellular targets that have long beenconsidered inaccessible. Our Endosomal Escape Vehicle(EEV™

• therapeutics are designed to enable the efficientintracellular delivery of a wide range of therapeutics into avariety of organs and tissues, resulting in an improved therapeuticindex. Through this proprietary, versatile and modular approach,Entrada is advancing a robust development portfolio of RNA
• andprotein-based programs for the potential treatment of neuromuscularand ocular diseases, among others.

Our lead oligonucleotideprograms are in development for the potential treatment of peopleliving with Duchenne who are exon 44, 45, 50 and 51 skippingamenable. Entrada has partnered to develop a clinical-stageprogram, VX-670, for myotonic dystrophy type 1. We are a tight-knitteam of experts and leaders in both therapeutic development andrare diseases and are excited to grow and attract colleagues whoare ready to join a high-energy, dedicated team that likes to getthings done and dramatically improve the lives of patients andtheir families. The Perfect Addition to Our Team You are passionateabout clinical trial research and driven to advance drugdevelopment through rigorous analytics. With a strong foundation instatistics and clinical methodologies, you combine classicaltechniques with cutting-edge innovations. You thrive in fast-pacedsettings, handle competing priorities with ease, and eagerly stepin where needed. You are results-oriented and collaborative, andyou thrive when build strong relationships across teams to deliverimpactful solutions. The Opportunity Reporting to the SeniorDirector, Head of Biostatistics, this individual will contribute todaily statistical activities and support the development ofstatistical approaches for clinical trials. Working closely withinternal and external stakeholders, you will help manage a growingportfolio of trials. This role also offers the opportunity tosupport the continued growth of the biostatistics function atEntrada and gain valuable experience in a collaborative, fast-pacedenvironment. Responsibilities Support statistical strategy forassigned drug programs, including input to clinical developmentplans, clinical study concepts and protocols design, SAPs, clinicalstudy reports, regulatory documentation and associatedpublications. Accountable for oversight of the production ofbiostatistics 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 therandomization procedures and oversight of the production ofrandomization lists. Review study Case Report Forms, datamanagement plan and other data management related documentation toensure that specific statistical requirements defined in the studyprotocol are met. Oversee outsourced statistical CRO activities anddeliverables, ensuring high quality and timely delivery. Produceinnovative tools and methodologies for statistical analysis throughliterature review. Participate in the development of departmentstrategies and cross functional initiatives on standards,infrastructure, and processes. The Necessities At Entrada, ourpassion for science, our devotion to patients and our values drivesour behavior: Humanity

• We genuinely care about patients and aboutone another. Tenacity
• We are relentless and persistent in thepursuit of developing therapies for patients. Creativity
• We arecreative problem solvers. Collaboration
• We are more than the sumof our parts. Curiosity
• We have a growth mindset and pushconventional thought and theory.

To thrive on our team, you willneed to come with: Ph.D. in Statistics or a related field, with 6years of experience in statistical analysis within thebiotech/pharmaceutical industry. Experience with a broad array ofstatistical approaches and experience in proposing novel approachesto support acceleration of clinical programs. Knowledge in thelatest developments in the analytical world including machinelearning and artificial intelligence is a plus. Solid understandingof regulatory guidelines on drug development, regulatorysubmissions, and statistical practice. Strong statisticalprogramming skills (R, SAS, Python). Understanding of regulatoryguidelines related to submission of datasets using CDISC,development of SDTM and ADaM specifications. Previous vendormanagement experience is preferred. Excellent verbal and writtencommunication skills with a strong attention for detail. This is aUS based remote position, with preference given to local NewEngland based candidates. This role will require a minimumquarterly travel to the Entrada Therapeutics Headquarters locatedin Boston, MA. LI-JF1 LI-Remote The Perks By becoming a team memberhere at Entrada, you’ll have access to competitive health, dental,and vision coverage, as well as life insurance, and short term andlong-term disability insurance. We value work life balance, you’llbenefit from discretionary time off, paternity leave, and anexcellent 401(k) package. We also offer a generous transportationstipend to commute as you wish. Our location in the vibrant andgrowing Seaport District is close to all the best that the city ofBoston has to offer. Entrada Therapeutics is an equal opportunityemployer. Qualified candidates will receive consideration foremployment without regard to race, color, religion, nationalorigin, gender, sexual orientation, gender identity or expression,age, mental or physical disability, and genetic information,marital status, citizenship status, military status, protectedveteran status or any other category protected by law. Third PartyStaffing Agencies Entrada does not accept unsolicited resumes fromany source other than directly from candidates. For the protectionof all parties involved in the recruiting process, resumes willonly be accepted from recruiters/agencies if a signed agreement isin place at the inception of the recruiting effort and authorizedfor a specified position. Unsolicited resumes sent to Entrada fromrecruiters/agencies do not constitute any type of relationshipbetween the recruiter/agency and Entrada and do not obligateEntrada to pay fees if we hire from those resumes. PrivacyStatement Entrada Therapeutics, Inc. (the ” Entrada ,” ” we, ” “us, ” or ” our “) respects your privacy and we want you to befamiliar with how we collect, use, share, or otherwise process,your Personal Information. Please reference our privacy statementhere to understand how and when your data is being used.