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Senior Manager, Statistical Programming
PTC Therapeutics, Inc.. Lead statistical programming activities for assigned clinical development studies and programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in statistical programming and analysis within clinical development, utilizing SAS and R to produce accurate outputs and reports. Proven ability to collaborate with cross-functional teams and CROs while managing multiple projects in a fast-paced environment.
Highest-signal resume keywords
SAS Programming SkillsStatistical AnalysisClinical Data AnalysisCDISC ExperienceCollaboration with CROs
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Statistical ProgrammingSASBase SASSAS/StatSAS/GraphSAS MacrosODSR ProgrammingStatistical Analysis PlansData Analysis
Soft Skills
Excellent Communication SkillsProblem-Solving SkillsPlanning and OrganizationTime ManagementAdaptability
Tools & Technologies
Database SystemsStatistical SoftwareClinical Data Management Tools
Industry Keywords
PharmaceuticalBiotechnologyCRONew Drug ApplicationsMarketing Authorisation ApplicationsClinical DevelopmentClinical Data Interchange Standards Consortium
About the role
Key responsibilities & impact- Lead statistical programming activities for assigned clinical development studies and programs
- Ensure timely statistical analyses of clinical data according to protocols and Statistical Analysis Plans
- Develop statistical programs and produce programmed outputs for integrated scientific reports, directly or through CRO oversight
- Participate in study team meetings as a Biostatistics representative
- Communicate statistical issues and serve as a statistical/programming resource to development teams
- Participate in assessment, selection and evaluation of CROs
- Review Case Report Forms (CRFs), CRF annotations, Statistical Action Plans, TLGs and TLG shells
- Interact with CROs to ensure statistical analyses and outputs are accurate and consistent with agreed deliverables
- Work with vendor staff to characterize and resolve data analysis issues
- Create or review derived dataset specifications and related analysis datasets
- Develop SOPs and training guidelines related to statistical programming as needed
- Perform other tasks and assignments specified by management
Requirements
What you’ll need- Master’s degree in a quantitative science discipline (e.g., Statistics, Mathematics, Computer Science)
- Minimum of 5 years of experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment
- Demonstrated and applied SAS programming skills, including Base SAS, SAS/Stat, SAS/Graph, SAS macros, and ODS
- Good understanding of database systems
- Working knowledge of R
- Clinical Data Interchange Standards Consortium (CDISC) experience
- Knowledge of clinical data analysis and reporting process as it relates to drug development
- Excellent verbal and written communication skills
- Ability to work independently and collaboratively in a fast-paced, matrixed, team environment
- Excellent problem-solving skills and ability to adapt to changing priorities and deadlines
- Excellent planning, organization and time management skills, including ability to support and prioritize multiple projects
- Experience working with CROs preferred
- Experience supporting New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs) submissions preferred
- Up to 20% travel
Benefits
Comp & perks- Short- and long-term incentives
- Medical plan
- Dental plan
- Vision plan
- Retirement savings plan