Associate Director / Director Statistical Programming

Location
San Carlos, California
Posted
May 06, 2022
Ref
o9aSifwd
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Alkahest acknowledges the crucial role data plays within Research & Clinical Development Programs, from improved clinical trial patient selection to real world evidence (RWE). We are seeking an experienced statistical programmer to develop our Biometrics programming infrastructure.

As the Associate Director/Director of Statistical Programming, reporting directly to the VP of Clinical Biometrics, you will build and implement a programming library to summarize and describe the data collected from our clinical trials. S/he will need strong SAS programming skills, communication skills, and an innovative mindset to transform the way we use clinical data to bring our medicines to patients. S/he will also build up external partnerships to assist in implementing our projects when internal resources are insufficient.

Responsibilities

  • Create specifications for derived/analysis datasets
  • Program analysis datasets, tables, figures, and listings to support the analysis of clinical trial data using SAS
  • Generate SDTM domains, ADaM datasets, and Define.xml files
  • Programming support to provide supplemental or exploratory analyses for regulatory authorities or any other internal and external ad-hoc requests
  • Perform quality control for SAS programs and other study data-related documents (e.g., presentations and reports)
  • Document the quality control review process
  • Review output across programs to ensure consistency
  • Review, maintain, and approve study documents per standard procedures
  • Program, test, and document global utility programs and tools in accordance with standards and validation procedures
  • Provide technical oversight and leadership in the area of data reporting
  • Participate in the development and/or maintenance of departmental procedures and standards
  • Assist in creation of table mockups collaboratively with a biostatistician
  • Serve as the primary project team representative, delegating work as appropriate
  • Mentor programmers as the team expands in size

Qualifications

  • BS/MS in Biostatistics/Statistics/Mathematics or related field
  • 10+ years of experience in Biotech/Pharma R&D business function, medical device industry or equivalent; global experience strongly preferred
  • Demonstrated experience in early and mid-stage clinical development programs
  • SAS Certified Advanced Programmer for SAS 9 or equivalent proficiency in Base SAS®, SAS/STAT and SAS/ACCESS software
  • Proficient in SAS Macro Programming
  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
  • Excellent communication and interpersonal skills to effectively collaborate with others
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines