Lead Statistical Programmer

Lead Statistical Programmer

Long Term Contract

Bridgewater, New Jersey

Onsite Opportunity

Visa- No Cpt/H1b

Basic Qualifications

Education/Training: MS in statistics or related disciplines

Skill(s):

Strong, hands-on individual with a high degree of technical competence and experience.

Work with passion to deliver on tight timelines; Excellent communication skills (both oral and written).

Experience: Senior programmer with at least 8 years of R and SAS programming experience in the pharmaceutical industry in support of clinical trial statistical analyses and reporting; and regulatory submissions (NDA,

BLA, IND, or Global Equivalents). In-depth knowledge and experience of CDISC SDTM, ADaM, data specifications, Define.xml, and CFR 21 Part 11 compliance. Effective team player in building strong cross-functional relationships and creating success. Expertise needed, required in developing Figures, Graphs using R, SAS.

General Responsibilities:

The Associate Director of Statistical Programming provides technical expertise in all programming related activities and processes in successful planning and execution of all pre-planned and/or ad-hoc programming. Ensuring that all statistical deliverables meet the defined timelines and quality expectations and that all programming complies with regulatory requirements.

Primary Objectives:

1. Acts as an expert on statistical programming, operational data standards, SDTM, ADaM and CDISC

2. Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDlSC SDTM format

3. Works in a team environment providing technical expertise and solving clinical trial data management and reporting problems of moderate to high complexity within budget and customary timeline constraints while

assuring high quality standards

4. Provides programming leadership in CSR and ISS/ISE related activities and detailed planning and seamless execution of e-submission activities

5. Interacts with other departments (i.e. Clinical Data Management, Biostatisticians, Clinical Operations and RegulatoryTeams, etc.) to resolve issues pertaining to duties assigned and ad hoc requests

6. Conducts oversight management of vendors, assesses the quality of clinical trial information (i.e. data sets, tables, listings, graphs, etc) provided to the Biostatistics Department in support of clinical trial submissions to regulatory authorities, for publications, etc

7. Prepares highly effective documentation for programs

8. Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Based upon job requirements, employee may be required at times to attend meetings including travel out of state over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. Employee is required to have a valid driver s license and means of transportation.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be able to fly via commercial air carrier.

This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.