Associate Director Statistical Programming
Associate Director Statistical Programming
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Job Description
Description
Job Title:
Associate Director Statistical Programming
Location:
San Diego CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Finance ID:
Biometrics
P
Profoundly Improve Peoples lives by Revolutionizing the Delivery of RNA Therapeutics
At Avidity Biosciences we are passionate about the impact of every employee in realizing our vision of improving peoples 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 solutionoriented 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 peoples lives by delivering a new class of RNA therapeutics Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform Avidity demonstrated the firstever 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 inSan Diego CA.For more information about our AOC platform clinical development pipeline and people please visitand engage with us onLinkedInandTwitter.
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 Aviditys clinical programs as well as implementing process improvements and department initiatives.This position will work crossfunctionally 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 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 crossprogram 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 () in trial design domains program full scope of SDTM domains including SUPPxx and RELREC
- Experience in writing ADaM specification () and programming ADaMs
- Experience ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy)
- CDISC submission package experience including 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 jobspecific training offered by industry and an education reimbursement program.
Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego CA
92121
O:
F:
Required Experience:
Director
Employment Type
Full-Time
