Director, Statistical Programming

GENERAL SUMMARY:

TheDirector ofStatistical Programmingwill focus on applying programmingmethodologyfor implementing statistical analyses using SAS for in-house deliverables and performing quality review of outsourced statistical willparticipateas active members of a cross-functional team to planleadand execute the tasksrequiredto support the assigned programs.

MAJOR DUTIES &RESPONSIBILITIES:

• Provide statistical programmingleadershipfor an assignedindicationthat may consist ofmultiple clinical trials

• Work closely with biostatisticians to review the SAP and responsible in the development of data/analysis program specification based on the SAP

• Maintain complete and auditable programming documentations for analysis of clinical trials

• Contribute to the developmentdocumentationand maintenance of reusable programming code library

• Collaborate with IT to set-up/maintainthe statistical computing infrastructure (e.g. SAS server)

• May act as a biostatistician on small-scale projects

• Collaborate with various functions to ensure robust CRF/EDC development and quality data collection for the assigned clinical trials

• Oversee the biometrics vendors to ensure the prompt and quality statistical deliverables

• Provide quality review of outsourced statistical deliverables (including inhouse double programming to QC as needed) and coordinate the inhouse review comments

• Contribute to the development of functional-level standards SOPs and work instructions and templates

• Stay abreast of industry development in biostatistics/statistical programming fields and apply toappropriate systemsand processes

• Other duties as assigned nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

QUALIFICATIONS:

Education:

• B.A./ statistics computer science or other quantitative science majorrequired

• Advanced degree (M.A./M.S.) preferredor equivalent experience

Experience:

• B.A./B.S. with 17 years or M.A./M.S. with 13 years

• Submission

• Experience in ophthalmology and/or biologic/gene therapy a plus

Other Qualifications/Skills:

• Strong SAS programming skills required withproficiencyin SAS/BASE SAS Macros SAS/Stat and ODS (proficiencyin SAS/SQL SAS/GRAPH or SAS/ACCESS is a plus)

• Proficiencyin R programming a plus

• Proficiencyin Microsoft Office Apps such as WORD EXCEL and PowerPoint (familiar with the Chart features in EXCEL/PowerPoint a plus)

• Good understanding of standards specific to clinical trials such as CDISC SDTM andADaM MedDRA WHODRUG

• Experience with all clinical phases (I II III and IV) is desirable

• Experience with BLA/IND submissions is strongly desirable

• Good understanding of regulatory requirements for submission-related activities (e.g. CDISC CDASH eCTD) and CRT packages (e.g. XPTs Define/xml reviewers guide analysis metadata report executable programs) is desirable

• Able to run the P21 checks is a plus

• Knowledge of applicable GCP/FDACHMP//ICH/HIPPA regulations

• Displays excellent organization and time management skills excellent attention to detail and ability to multi-task in a fast-paced environment with shifting priorities and/or conflicting deadlines

• Excellent written and verbal communication skills andstrong teamplayer withdemonstratedtrack recordof success in cross-functional team environment

• Proven conceptualanalyticaland strategic thinking

• Good interpersonal and project management skills

• Proactivelyidentifiesrisks issues andpossible solutions

Travel:<5%

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists hands and/or fingers. Fingering: Picking pinching typing or otherwise working primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideasby means ofthe spoken word.

• Physical Requirements -Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of forcefrequentlyor constantlyto lift carry push pull or otherwise move objects including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing arerequiredonlyoccasionallyand all other sedentary criteria are met.

• Working Conditions - The worker is notsubstantially exposedto adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $228000 - 256000

Pleasenotethe base salary compensation range and actual salary offered to the final candidatedependsonvarious factors:candidatesgeographical location relevant work experience skills and years of experience.