About the Role:Plays a lead role in designing, developing, testing, maintaining, validating, and documenting SAS programs to evaluate clinical data and meet the project requirements for SAS statistical programming efforts for clinical and non-clinical projects and studies. Provides advanced technical expertise to the development of programming standards and procedures. This role will be on-site at our beautiful campus, the ideal candidate will live in the San Diego area.
Your Contributions (include, but are not limited to):- Provides advanced technical statistical programming leadership to the Statistical Programming function within Biometrics and be a technical resource for statistical programmers
- Participates in hiring, training, and oversight of statistical programmers to support the analysis and reporting of data from clinical and nonclinical studies for all corporate development programs
- Serves as the lead on projects and primary Statistical Programming point of contact on large, multidisciplinary projects company wide
- Provides technical direction in the development and implementation of programming standards and conventions, building statistical programming infrastructure
- Contributes to the assessment of workload and projects in order to ensure appropriate programming resources are available to complete tasks in a timely manner
- Oversees and validates vendor programming activities such as CDISC implementation, analysis reporting, and programming conventions.
- Supports creation and validation of e-submission requirements (i.e. annotated CRF, datasets files, define documents)
- Serves as primary/lead programmer for agency reporting deliverables such as DSUR/Annual Report and IB updates
- Performs the function of lead and/or quality control statistical programmer on projects as needed
- Performs other duties as assigned
Please note: this is an on-site position only.
Requirements:- BS/BA degree in computer science, mathematics, statistics, or related discipline AND 6+ years of experience in the Biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS, (Base, Stat, Macro, graph), CDISC data structures. In addition, must have at least three years of experience serving in a supervisory or lead capacity. Experience managing large projects and external vendors. OR
- Master's degree in computer science, mathematics, statistics, or related discipline AND 4+ years of similar experience noted above OR
- PhD in computer science, mathematics, statistics, or related discipline AND 2+ years of similar experience noted above
- Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
- Works to improve tools and processes within functional area
- Developing reputation inside the company as it relates to area of expertise
- Ability to work as part of and lead multiple teams
- Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
- Excellent computer skills
- Excellent communications, problem-solving, analytical thinking skills
- Sees broader picture, impact on multiple departments/divisions
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
- Excellent project management skills
- Proficiency with Word, Excel, and PowerPoint is required as is the ability to communicate effectively both verbally and in writing
- Advanced SAS programming skills and expertise in the development and implementation of statistical programming SOPs and processes in a clinical environment
- Knowledge of all aspects of writing, validating, and documenting statistical programs, and of creating integrated programming libraries and systems
- Experience in project management with minimum supervision. Demonstrate ability to effectively organize and manage multiple assignments with challenging timelines across multiple personnel
- Advanced understanding of relational databases and experience working with complex data systems
- Demonstrates expert knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
- Advanced programming skills in SAS, (Base, Stat, Macro, graph), R, STAT or similar
- Advanced knowledge of SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains
#LI-SA1
The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
