Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visitwww.Encoded.com.

　　Manages projects, individual contributors (employee and/or contractors), and/or vendors. Actively participates in hands-on programming work and oversight as needed. Builds out department (standards, applications, and processes) and SAS infrastructure (macros and programs) to summarize clinical data in the form of tables, listings, and figures (TLFs). Participates in DB, eCRFs, SAP, CSR, abstracts, and manuscript review as needed. Role will be hands-on initially. Function and department building opportunities will follow as clinical programs mature

　　Workplace Model: Hybrid

　　Responsibilities

　　Work with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver data deliverables.

　　Develops SAS macros and programs to generate tables, listings, and figures (TLFs) according to the statistical analysis plan (SAP).

　　Create CDISC SDTM and ADaM files, SAS export files, and define.xml for electronic submissions.

　　Draft analysis dataset specifications.

　　Review deliverables for accuracy (e.g., TLFs for study reports, submission documents, publications, meeting presentations, and ad-hoc requests).

　　Manage programming activities and oversee CROs as needed.

　　Generate ad-hoc analyses.

　　Create and maintain SOPs related to statistical programming and ensure processes are consistently followed.

　　Provide input on study-related documents generated within the biometrics team (e.g. CRFs, SAP, DMP, DVP, and edit check specifications, etc.).

　　Provide time and resource estimates for project planning.

　　Participate in Human Resources activities for the department (staffing, performance management and employee development).

　　Buildout statistical programming team.

　　Requirements

　　M.S. or Ph.D. in statistics, biostatistics, or closely related field with a minimum of 10 years pharmaceutical/biotech/CRO related SAS programming in support of clinical trials for regulatory submission.

　　Skilled in programming with SAS (Base SAS, Proc SQL, ODS). Knowledge of R language a plus.

　　Excellent working knowledge of CDISC SDTM and ADaM models.

　　Experience with Pinnacle-21 compliance.

　　Prior managing experience is preferred.

　　Ability to follow guidelines and specifications on validation procedures and data transfer procedures.

　　An aptitude for quantitative problem solving with the capacity to troubleshoot and work independently.

　　Solid verbal and written communication skills.

　　Flexibility: ability to adapt to changing priorities.

　　Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance.

　　Experience working in a remote environment.

　　The anticipated salary range for candidates who will work in California is $195,000 - $227,000 (Associate Director) and $231,000 - $265,000 (Director). The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Encoded Therapeutics is a multi-state employer and this salary range may not reflect positions that work in other states.

　　A hired applicant may be eligible for an annual bonus as well as equity under the company’s stock plan.

　　Benefits

　　Comprehensive benefits package, including competitive employer premium contributions

　　Meaningful stock option grants

　　PTO, sick time, and holiday pay

　　Generous Parental Leave program

　　Pre-tax medical and dependent care programs

　　STD, LTD, Life and AD&D

　　Professional development opportunities

　　Team-building events

　　Fully stocked kitchen

　　Purple Tie dry cleaning service

　　Fitness center

　　Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan. Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave. Employees will also enjoy designated paid holidays throughout the calendar year.

　　Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.

　　If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.

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