Director Biostatistics
Director Biostatistics
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Job Description
Description
Job Title:
Director Biostatistics
Location:
San Diego CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Finance ID:
Biometrics
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 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 visit and engage with us on LinkedIn and Twitter.
The Opportunity
TheDirector of Biostatistics will serve as a program statistical lead andmayleadone ormorestudies.The position will providetechnical leadership andbiostatisticalsupportforclinical trial designconductevaluationandinterpretation ofstudy results.This position will also involveregulatoryresponsesandfiling activitiescontributingtostatistical analyses and preparing the submission data package.
Additionally the position willbeinvolvedin departmentor crossfunctional departmental standards processestrainingand initiatives.
What You Will Contribute
- Serve as a lead statistician for a pivotal study or at the program level. Providestatistical support tocrossfunctionalteams.
- Provide input into product development strategy anddecisionmaking(e.g. considerations for interim analyses innovative designs comparisons withnatural history studiesorcompetitorsetc.
- Contribute to research in advanced statistical methodologies
- Lead/support the regulatory interaction and submission activities
- Review CRFs and other studydocumentationand draft statistical analysis plan (including ISS/ISE)and develop TFL shell and specification
- Manage CRO andoverseethe of statistical analysesreviewstatistical outputs
- Create/review study randomization filesandcontribute to the protocolIDMC charter andstudyrelateddocumentauthoring
- Presentandinterpretstudy results and author and review regulatory documents(including CSR)and publications.
- Work withthebiometrics team to providethedata package relevant for submission orreimbursement.
- Contribute to developingdepartmentstandards procedures and initiatives
- Mentor junior statisticians and summer interns
What We Seek
- GenerallyPhDin Biostatistics or Statisticswith10 years(or MS with 12 years)of relevant pharmaceutical experience
- Experienced in leading an indication and phase 3 studies independently
- Experienced in NDA / BLA / MAA activities as a key contributor fromastatistics perspective and direct involvement in regulatory interaction
- Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs.
- Experienced inhandson studylevelwork including authoring SAP TFL specificationandvalidatingoutputs
- KnowledgeofCDISC including SDTM ADaM and controlled terminologies
- Havea working knowledge of all appropriate relevant regulatory guidance documents (e.g.ICH FDAand EMEA)
- Ability to respond to regulators inquiries for products undergoing registration and approved products
- Demonstratedorganizeddetailorientedandproblemsolvingskillsandability to prioritize and complete multiple tasksto meet the timeline.Flexible toadapttochange.
- Strong communication and interpersonal skills with the ability to work collaboratively in a team environment.
- Familiar with SASandother statisticalsoftware(i.e. R Pythonetc.
- The preferred candidate will also have career experience working in raredisease experience with using statistical methods to analyze longitudinal data and advanced statistical knowledge such as adaptive designrealworlddata comparison machine learningandAIapplications.
What We Will Provide To You
The base salary range for this role is $232750 $257250. 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 include 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
