Associate Director, Statistical Programming

Job Title:

Associate Director, Statistical Programming

Location:

San Diego, CA / Hybrid / Remote

Position type:

FLSA:

Full time

Exempt

Department:

Finance ID:

Biometrics

7575-2024-3-P

Strive to Bring a Profound Difference to our Patients

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients. 

 

Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.

The Opportunity

The Associate Director, Statistical Programming is a programming leader accountable for biostat/programming vendor oversight, management and quality control. This position will also be responsible for internal statistical programming deliveries across Avidity’s clinical programs, as well as implementing process improvements and department initiatives. This position will work cross-functionally with biostatisticians, clinical data management, clinical operations, clinical development, biomarker, bioanalytical, regulatory affairs, quality assurance, and IT, as needed.

What You Will Contribute

• Lead programming activities within department of Biometrics
• Lead oversight for Vendor deliveries including SDTM, ADaMs, TFLs, DMC, DSUR, interim analysis, final CSR analysis
• Lead programming support for internal biometrics deliveries to support Clinical development planning
• Collaborate with Biostatistics, Clinical Data Management, Clinical Development, Biomarker, Bioanalytics teams. Provide subject matter expertise
• Provide infrastructure support, oversee biometrics SAS server, set up and maintain standard directory, author technical user guides for biometrics tools and utilities, develop SOPs, working instructions for statistical programming group
• Establish and maintain macro libraries that support biometrics clinical studies activities, including TFL generation, controlled terminology, SDTM/ADaM specs and generation
• Establish and maintain scripts, tools that support submission activities, including BIMO, define.xml, hyperlinked submission documents
• Contribute to or drive the development of best practices to improve quality, efficiency and effectiveness within function
• Ensure compliance to CDISC standards
• Contribute to or lead technical initiatives, help establish Avidity cross-program standards

What We Seek

• BS degree or above in Statistics, Mathematics, Computer Science, or Life Science
• At least 12 years of experience with clinical SAS programming in pharmaceutical or biotechnology industry
• Quick learner and problem solver, be flexible and adaptive
• Strong skill in SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/ACCESS, SAS/BASE, SAS/STAT, SAS/ODS, SAS/EG, SAS/Studio, SAS/REPORT, SAS/ACCESS, and SAS annotate facility
• Fluent SAS skill in generating Tables, Listings, Figures
• Extensive knowledge in the latest CDISC standards, specially SDTM and ADaM
• Able to annotate SDTM aCRF, write specifications (define.xml) in trial design domains, program full scope of SDTM domains including SUPPxx and RELREC
• Experience in writing ADaM specification (define.xml) and programming ADaMs
• Experience ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy)
• CDISC submission package experience including define.xml, cSDRG, ADRG, CT
• Good knowledge of MedDRA and WHODrug medical dictionaries
• Experience with central lab, toxicity grade, CTCAE
• Experience with rare diseases preferred
• Experience with management of CROs/Biostats Vendors preferred

What We will Provide to You:

• The base salary range for this role is $190k-$210k. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
• A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

Avidity Biosciences

10578 Science Center Dr. Suite 125

San Diego, CA

92121

O: 858-401-7900

F: 858-401-7901