Statistical Programmer (PART-TIME, CONTRACT)

The Organization

Whats happening at Entrada Therapeutics Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.

Our Endosomal Escape Vehicle (EEV)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues resulting in an improved therapeutic index. Through this proprietary versatile and modular approach Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular and ocular diseases among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44 45 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program VX-670 for myotonic dystrophy type 1.

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy dedicated team that likes to get things done and dramatically improve the lives of patients and their families.

The Opportunity

We are seeking a highly skilled and detail-oriented Statistical Programmer to join our team on a part-time contract basis. This role will support biometric initiatives by developing and validating statistical programs for data analysis reporting and presentation. The ideal candidate will have strong experience in both SAS and R programming and a solid understanding of clinical trial data standards and regulatory requirements. This position reports to the Senior Director Biometrics and will collaborate closely with cross-functional teams including Biostatistics Data Management and Clinical Operations.

Responsibilities

• Develop validate and/or maintain statistical programs using SAS or R to support clinical trial data analysis reporting and regulatory submissions.
• Generate CDISC-compliant datasets (SDTM and ADaM) and outputs including tables listings and figures (TLFs).
• Perform quality control checks of programs and outputs to ensure accuracy and compliance with internal standards and regulatory guidelines.
• Collaborate with biostatisticians to implement analysis plans and customize outputs for target audiences.
• Support programming deliverables for ongoing clinical studies including interim analyses and final study reports.
• Participate in the review of statistical analysis plans (SAPs) TLF shells and other study documentation.
• Contribute to process improvement initiatives and development of standard macros and programming best practices.
• Communicate and escalate risks or issues related to programming deliverables in a timely manner

The Necessities

At Entrada our passion for science our devotion to patients and our values drives ourbehavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are relentless and persistent in the pursuit of developing therapiesfor 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:

• Bachelors or Masters degree in Statistics Computer Science or a related scientific discipline.
• Minimum 5 years of experience in clinical programming within the pharmaceutical biotech or CRO industry.
• Proficiency in SAS (Base Macro Graph) or R programming is required.
• Strong understanding of CDISC standards (SDTM ADaM) and experience with electronic data capture (EDC) systems and integration of data from multiple sources.
• Familiarity with ICH GCP guidelines and regulatory submission requirements.
• Experience with rare disease therapeutic areas is a plus.
• Excellent problem-solving skills and attention to detail.
• Strong verbal and written communication skills.
• Ability to work independently and manage multiple priorities in a remote setting.
• This is a US-based remote part-time contract position with flexible hours averaging 10 hours per week. Occasional travel to Entradas Boston headquarters may be required.#LI-JF1 #LI-Remote

Equal Opportunity Employer

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race color religion national origin gender sexual orientation gender identity or expression age mental or physical disability and genetic information marital status citizenship status military status protected veteran status or any other category protected by law.

Third Party Staffing Agencies

Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.

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