Senior Manager/Manager Statistical Programming

REPORTS TO (POSITION): Director Statistical Programming

LOCATION: SOUTH SAN FRANCISCO, CA

DEPARTMENT NAME: Biometrics

HR DESIGNATIONS: PAY STATUS – EXEMPT 

Objective of Position

The Senior Manager is responsible for the planning and tracking of Statistical Programming staff activities to ensure efficient use of resources.  Project-level responsibilities include the oversight and management of workflow in generation of study-specific and ad-hoc clinical data listings, summary tables, and figures.

Essential Duties/ Responsibilities

  • Manage and develop team members
  • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data
  • Create CDISC SDTM and ADaM files, SAS transport files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources
  • Performs data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS
  • Review Data Management Plan, Data validation plan and edit check specifications
  • Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements
  • Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection
  • Recognizes inconsistencies and initiates resolution of data problems
  • Acts as a liaison between statistical programming, subcommittees and project teams as needed
  • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results
  • Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles
  • May serve as external spokesperson for the organization
  • Acts independently to determine methods and procedures on new assignments
  • May provide guidance to other lower level personnel
  • Works closely with Biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP)
  • Develop SAS coding and table templates for preparing, processing and analyzing clinical data
  • Create/acquire tools to improve programming efficiency or quality
  • Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues
  • Experience with integrated summaries (ISE/ISS) and Clinical Study Reports

Requirements

  • Prior management/supervisory experience
  • Ability to use professional concepts to achieve objectives in creative and effective ways.
  • Experience in the analysis of complex Oncology clinical trial data
  • Experienced in managing in multiple project
  • Ability to use professional concepts to achieve objectives in creative and effective ways.

Education/ Training

  • Bachelor/Master degree in Statistics, Life Sciences, Computer Sciences, or Mathematics with a minimum 11 years Pharmaceutical/Biotech programming experience with 3+ years of management experience
  • Experience working with Oncology trials and NDA submission experience is highly desirable
  • Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat


Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. This document may be changed at management’s discretion.

Acerta Pharma is an equal opportunity employer. Acerta Pharma will consider all qualified applicants for employment, and all qualified contractors for Acerta Pharma contract positions, without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. Acerta Pharma only employs individuals, and engages contractors, with the right to work in the country/ies where the role is based.