Sr. Statistical Analyst - San Diego, CA | Biospace
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Sr. Statistical Analyst

Ignyta Inc

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Location:
San Diego, CA
Posted Date:
8/1/2017
Position Type:
Contract
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Pharmaceutical, SAS,

Job Description

Position Summary:
As part of Data Science team, this role will lead programming support for multiple complex oncology studies in multiple stages of clinical development. This role will interact with Biostatistics, Clinical Data Management, Medicals, Clinical Operations and Regulatory to design, write, and validate SAS® programs in accordance with company, industry, and regulatory requirements.


Duties & Responsibilities:
Essential duties and responsibilities include the following:

1.Essential duties and responsibilities include the following:
2.Lead programming support for complex oncology studies, provide input to timeline development, and resource assessment
3.Create/review programming plan, specifications for datasets and TLFs. Advanced knowledge with CDISC conventions, i.e., SDTM and ADaM models and experienced in implementing these models.
4.Develop and validate SAS® programs to produce high quality deliverables for in-house projects within set timelines in accordance with company and regulatory requirements. The deliverables include SDTM and ADaM datasets, define.xml, tables, listings and figures.
5.Perform conformance checking of SDTM and ADaM datasets using Pinnacle 21; ensure datasets are in compliance with submission standards
6.Manage CRO programming activities; review and validate deliverables produced by CROs, independently provide solutions to issues raised by CROs
7.Lead the creation and review of analysis file specification for ISS and ISE; program and validate ISS and ISE.
8.Having advanced level of programming expertise, create and validate global SAS macros and utilities to automate standard and frequent tasks
9.Review and provide input on documents produced by other Data Science functions such as: statistical analysis plans; TFL shells; data management plans; data transfer plans; electronic data entry screens; and case report forms.
10.Contribute to the development and continuous improvement of programming process and standard
11.Effectively communicate in a project team environment, within department, among functional groups and external collaborators
12.Perform other programming duties as assigned

Requirements

Essential duties and responsibilities include the following:

-   Lead programming support for complex oncology studies, provide input to timeline development, and resource assessment

-   Create/review programming plan, specifications for datasets and TLFs. Advanced knowledge with CDISC conventions, i.e., SDTM and ADaM models and experienced in implementing these models.

-   Develop and validate SAS® programs to produce high quality deliverables for in-house projects within set timelines in accordance with company and regulatory requirements. The deliverables include SDTM and ADaM datasets, define.xml, tables, listings and figures.

-   Perform conformance checking of SDTM and ADaM datasets using CDISC validation tool such as Pinnacle 21; ensure datasets are in compliance with submission standards

-   Manage CRO programming activities; review and validate deliverables produced by CROs, independently provide solutions to issues raised by CROs

-   Review analysis file specification for ISS and ISE; program and validate ISS and ISE.

-   Having advanced level of programming expertise, create and validate global SAS macros and utilities to automate standard and frequent tasks

-   Review and provide input on documents produced by other Data Science functions such as: statistical analysis plans; TFL shells; data management plans; data transfer plans; electronic data entry screens; and case report forms.

-   Contribute to the development and continuous improvement of programming process and standard

-   Effectively communicate in a project team environment, within department, among functional groups and external collaborators

-   Perform other programming duties as assigned.

Education/Experience:

-   Minimum of BS required in Computer Science, Statistics, Life Sciences or other related field
-   BS with 6+ years or MS with 4+ years of SAS programming experience in drug development in CRO or pharma/biotech company
-   Good written and verbal communication skills.